Bimodular contact lenses

ABSTRACT

Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include an inner optic portion configured to be disposed over the optical region of the cornea and having a central portion disposed between an anterior portion and a posterior portion. The inner optic portions configured to at least partially diverge from the shape of the cornea to provide at least one lenticular volume between a posterior surface of the inner optic portion and the cornea. The central portion may be characterized by a thickness from 50 μm to 900 μm and a modulus form 20 MPa to 1500 MPa.

This application is a continuation of U.S. application Ser. No.14/532,707, filed on Nov. 4, 2014, which claims benefit under 35 U.S.C.§119(e) of U.S. Provisional Application No. 61/900,947, filed on Nov. 6,2013, and U.S. application Ser. No. 14/532,707 is a continuation-in-partof U.S. application Ser. No. 13/865,780, filed on Apr. 18, 2013, nowissued as U.S. Pat. No. 9,423,632, which claims benefit under 35 U.S.C.§119(e) of U.S. Provisional Application No. 61/636,404, filed on Apr.20, 2012, and, each of which is incorporated by reference in itsentirety.

FIELD

The disclosure relates to ophthalmic lenses for correcting refractiveerror of an eye are disclosed. Ophthalmic lenses include a deformableinner portion and a deformable peripheral portion. When disposed overthe optical region of an eye, the inner portion is configured so thatengagement of the posterior surface against the eye deforms theposterior surface so that the posterior surface has a shape divergingform the refractive shape of the epithelium when viewing with the eyethrough the ophthalmic lens. The modulus of the inner portion is greaterthan the modulus of the peripheral portion and the ophthalmic lenses areconfigured to allow movement relative to the eye upon blinking of theeye and to be substantially centered on the optical region of the corneafollowing the blinking of the eye. When applied to the eye, the lensesare configured to provide one or more lenticular volumes between theposterior surface of the lens and the cornea. The disclosure furtherrelates to methods of correcting refractive errors of an eye such asastigmatism or spherical aberration using the ophthalmic lenses.

BACKGROUND

The eye includes several tissues that allow patients to see. The corneaof the eye is an anterior tissue of the eye that is clear in healthyeyes and refracts light so as to form an image on the retina. The retinais a posterior tissue of the eye that senses light from the image formedthereon and transmits signals from the image to the brain. The corneaincludes an outer layer of tissue, the epithelium, which protects theunderlying tissues of the cornea, such as Bowman's membrane, the stroma,and nerve fibers that extend into the stroma and Bowman's membrane. Thehealthy eye includes a tear film disposed over the epithelium. The tearfilm can smooth small irregularities of the epithelium so as to providean optically smooth surface and maintain eye health. The tear film isshaped substantially by the shape of the underlying epithelium, stroma,and Bowman's membrane, if present. The tear film comprises a liquid thatis mostly water and does include additional components, such as mucoidsand lipids. The many nerve fibers of the cornea provide sensation topromote blinking that can cover the cornea with the tear film. The neverfibers also sense pain so that one will normally avoid trauma to thecornea and also avoid direct contact of an object to the cornea so as toprotect this important tissue.

In the healthy cornea, the proper amount of hydration of the cornea,sometimes referred to as dehydration of the cornea, is maintained suchthat the cornea remains clear. The cornea includes a posteriorendothelial layer that pumps water from the cornea into the adjacentanterior chamber. The epithelium inhibits flow of water from the tearliquid into the cornea, such that the corneal stroma can be maintainedwith the proper amount of hydration with endothelial pumping. Theendothelial pumping of water from the cornea to maintain the properhydration and thickness of the eye is referred to as deturgescence. Whenthe corneal epithelium heals, the layer of cells forming over the defectcan be at least somewhat irregular in at least some instances, such thatthe vision of the patient can be less than ideal.

Following corneal surgery, such as refractive keratectomy, thepost-ablation cornea may have a complex shape, and many of the priorcommercially available lenses may not fit the ablated cornea as well aswould be ideal, and in at least some instances fitting of lenses can betime consuming and awkward. Commercially available contact lenses havinga rigid gas permeable (RGP) central portion and a soft peripheral skirtcan be difficult and/or time consuming to fit to the ablated cornea andmay not fit very well in at least some instances. The ablated cornea maycomprise an abrupt change in curvature near the edge of the ablation,and in at least some instances it can be difficult to fit such lensesnear the edge of the ablation. Also, at least some of the commerciallyavailable contact lenses may not be suitable for extended wear and maybe removed each day, which can be somewhat awkward for a patient and canresult in lack of compliance and lenses remaining in the eye longer thanwould be ideal in at least some instances.

Hybrid or bimodular contact lenses, lenses having a comparatively rigidcentral porition and a soft skirt are also used to correct refractiveerror of the eye such as astigmatism. Current products such as RGP andsoft toric lenses for correcting refractive error include a cylindricalcomponent in addition to any spherical corrective component that must bedetermined for each patient and oriented with respect to the opticalregion of the cornea to maintain optimal vision correction. Features areincorporated into the lens to maintain centration and radial orientationof the lens of the eye during wear. Because of the need to fit andorient the cylindrical corrective component, a large number of lensesmust be maintained in inventory and individually fit and selected foreach patient.

In light of the above, it is desirable to provide improved contactlenses for vision correction and coverings for treatments related toepithelial defects of the cornea, such as epithelial defects followingPRK. Ideally, these contact lenses and coverings would providetreatments that improve tear flow and avoid at least some of thedeficiencies of known techniques while providing improved patientcomfort and/or vision. It is also desirable to provide improved contactlenses for correcting refractive error that only require a spherical fitand provide comfort and vision correction as good as or better thancurrent toric lens products.

SUMMARY

Embodiments of the present invention provide improved ophthalmic devicesthat provide improved vision for extended amounts of time and can beused to correct refractive error or to treat normal eyes or eyes havingan epithelial defect, such as an epithelial defect subsequent torefractive surgery such as PRK. The device may comprise a contact lensand can provide improved tear flow such that the device can be left onthe eye to correct vision for an extended time. Devices may comprise awater inhibiting layer and one or more structures to pump tear liquidunder the water inhibiting layer of the device such that the device canremain in the eye and correct vision for an extended amount of time.Alternatively or in combination, the device may comprise, for example, asilicone or hydrogel layer extending along a posterior surface of thedevice coupled to fenestrations to provide hydration and patientcomfort. The silicone or hydrogel layer may fluidly couple the cornea tothe fenestrations so as to pass tear liquid and therapeutic agents froman anterior surface of the device through the fenestrations and siliconeor hydrogel to the cornea. In certain embodiments, the device comprisesa material having fenestrations and an outer portion shaped to contactthe conjunctiva to pump tear liquid when the eye blinks. The device maycomprise a deflectable outer portion having a resistance to deflectionsuch that a chamber or lenticular volume is formed when the device isplaced on the eye and the eye is open with the eyelids separated. Asilicone or hydrogel layer coupled to the fenestrations may extend alonga lower surface of the device at least a portion of the chamber. Theresistance to deflection of the deflectable outer portion can beconfigured such that the outer portion deflects inward toward the corneawhen the eyelid closes to pump tear liquid. The fenestrations can drawtear liquid into the chamber located under the device when the eye opensand the chamber can expands. The fenestrations may extend through thesilicone or hydrogel layer to provide pumping. Alternatively or incombination, the silicone or hydrogel layer may cover the posterior endof the fenestrations and the deflection of the outer portion canencourage movement of liquid and medicament along the silicone orhydrogel. The outer portion of the device comprises a sclera couplingportion shaped to contact the conjunctiva to define the chamber when thedevice is placed on the eye. The fenestrations and sclera couplingportion of the device can pass tear liquid away from the chamber whenthe eye closes and pressure of one or more eyelids urges the devicetoward the cornea such that the chamber volume decreases. In certainembodiments, opening of the eye so as to separate the eyelids reducespressure on the outer portion of the device such that the outer portionof the device over an outer portion of the cornea can separate from theouter portion of the cornea so as to draw liquid through thefenestrations and into the chamber located under the device. The scleracoupling portion of device may contact the conjunctiva to inhibit theflow of tear liquid under the sclera coupling portion when the eye opensand tear liquid is drawn through the fenestrations, for example withformation of a seal where the device contacts the conjunctiva. When theeye blinks subsequently, the pressure of the one or more eyelids canurge the device toward the cornea such that tear liquid can pass throughthe fenestrations, and the sclera coupling portion may separate slightlyfrom the conjunctiva to pass tear liquid under the sclera couplingportion, so as to rinse the cornea, the limbus, the conjunctiva and theunderside of the device with the pumped tear liquid. The device maycomprise a material having high oxygen permeability such as siliconesuch that the device may provide improved tear flow and high oxygenpermeability. This improved flow of tear liquid can allow the devicesuch as a contact lens to be worn for an extended time of at least aboutone week, for example thirty days or sixty days or more. The improvedtear flow can improve healing and vision of eyes with epithelialdefects, for example epithelial defects following PRK. Improved tearflow can also maintain health of the eye and facilitate longer wear.

In certain embodiments, a device comprises an inner optical componentfor vision, such as a lens, and an outer coupling component to hold theinner component in relation to the pupil to improve vision. The couplingcomponent may comprise a deflectable material that inhibits passage ofthe tear liquid through the material such that the tear liquid passesthrough fenestrations when the eye blinks and an eyelid exerts pressureon the optical component. The outer coupling component may comprisefenestrations to pass the tear liquid and the outer sclera couplingportion to contact the conjunctiva. The optical component may comprise afirst material characterized by a first modulus and first thicknesscorresponding to a first rigidity. The coupling component may comprise asecond material characterized by a second modulus and a second thicknesscorresponding to a second rigidity. The second material can be softer,e.g., have a lower modulus, than that of the first material and thesecond thickness can be less than the first thickness such that thecoupling component can be deflected with the eyelid, and such that thecoupling component can be deflected by an amount greater than theoptical component when the eyelids close to cover the first componentand the second component. The optical component can be more rigid thanthe coupling component, such that the optical component can providevision when the outer portion is deflected with one or more eyelids. Incertain embodiments, the optical component is configured to havesufficient rigidity to maintain a lenticular volume between theposterior surface of the lens and the cornea.

The alignment of the optical component to the pupil provided with thecoupling to the conjunctiva and underlying sclera can be beneficial forvision. In certain embodiments, the optical component can be held at asubstantially fixed location in relation to the pupil so as to provideimproved vision such as presbyopia correction and vision correction ofaberrations that may depend on location of the pupil such as measuredwavefront aberrations, spherical aberration, coma, and trefoil.

The optical component and the coupling component can be helpful toimprove vision and regeneration of the epithelium in eyes withepithelial defects. The optical component can smooth the cornea and maysmooth irregularities of the epithelium and ablated stroma. The couplingcomponent can support the optical component so as to resist slidingmovement of the optical component and provide an environment to promoteregeneration of the epithelium. The pumping of the tear liquid mayimprove tear flow to the regenerating epithelium near the epithelialdefect so as to promote regeneration of the epithelium over the defect.The pumping of the tear liquid can also promote delivery of amedicament, for example a steroid, to the ablated region so as toinhibit corneal infiltrates and haze.

In a first aspect, ophthalmic lenses for correcting a refractive errorof an eye are provided, the eye having a cornea with a refractive shapeextending across an optical region of the eye, the ophthalmic lenscomprising an inner optic portion configured to be disposed over theoptical region of the cornea; a posterior surface extending along theinner optic portion and configured so that engagement of the posteriorsurface against the eye deforms the posterior surface and so that theposterior surface has a shape diverging from the refractive shape of thecornea; and a peripheral portion of the ophthalmic lens disposedradially outward of the inner optic portion; wherein, the inner opticportion comprises an inner material characterized by an inner modulusand the peripheral portion comprises a peripheral material characterizedby a peripheral modulus; the inner modulus is greater than theperipheral modulus; and the inner modulus is from about 20 MPa to about1500 MPa.

In a second aspect, methods for correcting a refractive error of an eyeare provided, the eye having a cornea with a refractive shape extendingacross an optical region of the cornea, the method comprisingpositioning an ophthalmic lens on the eye so that an inner optic portionof the ophthalmic lens is disposed over the optical region of thecornea, wherein at least a portion of a posterior surface of thepositioned ophthalmic lens extends adjacent the eye and is deformed bythe eye; and wherein a shape of the posterior surface diverges from therefractive shape of the cornea so that the ophthalmic lens mitigates therefractive error.

In a third aspect, ophthalmic lenses for correcting a refractive errorof an eye are provided, the eye having a cornea with a refractive shapeextending across an optical region of the eye, the ophthalmic lenscomprising an inner optic portion configured to be disposed over theoptical region of the cornea, wherein the inner optic portion comprisesa central portion, an anterior portion disposed anteriorly to thecentral portion, and a posterior portion disposed posteriorly to thecentral portion; a peripheral portion of the ophthalmic lens disposedradially outward of the inner optic portion; a plurality offenestrations disposed within the inner optic portion, the peripheralportion, or both the inner optic portion and the peripheral portion; andat least some of the plurality of fenestrations are configured tomaintain tear fluid within one or more lenticular volumes between theposterior surface of the inner optic portion and the cornea; a posteriorsurface extending along the inner optic portion adjacent the eye andconfigured so that engagement of the posterior surface against the eyedeforms the posterior surface and so that the posterior surface has ashape diverging from the refractive shape of the cornea; and an anteriorsurface characterized by a spherical profile without a cylindricalcomponent; and wherein the central portion comprises a materialcharacterized by a modulus from about 20 MPa to about 1500 MPa.

In a fourth aspect, ophthalmic lenses for correcting a refractive errorof an eye are provided, the eye comprising a cornea with a refractiveshape extending across an optical region of the cornia, the ophthalmiclens comprising: an inner optic portion configured to be disposed overthe optical region of the cornea, wherein the inner optic portioncomprises a central portion, an anterior portion disposed anteriorly tothe central portion, and a posterior portion disposed posteriorly to thecentral portion; a posterior surface extending along the inner opticportion adjacent the eye and configured so that engagement of theposterior surface against the cornea deforms the posterior surface andso that the posterior surface has a shape diverging from the refractiveshape of the cornea and providing at least one lenticular volume betweenthe posterior surface and the cornea; an anterior surface extendingalong the inner optic portion characterized by a spherical profilewithout a cylindrical component; a peripheral portion of the ophthalmiclens disposed radially outward of the inner optic portion; and aplurality of fenestrations disposed within the inner optic portion, theperipheral portion, or both the inner optic portion and the peripheralportion; and at least some of the plurality of fenestrations areconfigured to maintain tear fluid within one or more lenticular volumesbetween the posterior surface of the inner optic portion and the cornea;wherein the central portion comprises a material characterized by amodulus from about 20 MPa to about 1500 MPa.

In a fifth aspect, methods for correcting a refractive error of an eyeare provided, the eye having a cornea with a refractive shape extendingacross an optical region of the cornea, the method comprisingpositioning an ophthalmic lens provided by the present disclosure on aneye comprising a refractive error, to correct the refractkive error.

In certain embodiments, a device comprises an inner portion comprisingan optical component and an outer portion comprising an couplingcomponent. An outer portion of the device may comprise an intermediateportion of a coupling component and an outer portion of the couplingcomponent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an eye suitable for use with an ophthalmic device asdescribed herein, in accordance with embodiments of the presentinvention.

FIG. 1-1A shows an ablated eye immediately following refractive surgeryresulting in an epithelial defect, suitable for remediation inaccordance with embodiments of the present invention.

FIG. 1A1 shows a device positioned on an eye and blinking of the eye, inaccordance with embodiments of the present invention.

FIG. 1A2 shows the device of FIG. 1A1 that is capable of pumping tearliquid under the device, in accordance with embodiments of the presentinvention.

FIG. 1A3 shows a schematic illustration of the devices of FIG. 1A1 andFIG. 1A2 pumping tear liquid when the eye closes, in accordance withembodiments of the present invention.

FIG. 1A4 shows a schematic illustration of the device of FIG. 1A1 andFIG. 1A2 pumping tear liquid when the eye opens, in accordance withembodiments of the present invention.

FIG. 1B 1 shows a device having a tricurve profile to fit the sclera ofan eye, which device may be used to fit an ablated cornea, in accordancewith embodiments of the present invention.

FIG. 1B2 shows a device having a tricurve profile to fit the sclera ofan eye with slopes of the curved profiles aligned so as to inhibitridges at the boundaries of the curved portions, in accordance withembodiments of the present invention.

FIG. 1B2-1 shows alignment of the slope of the lower surface of thecorneal contacting portion with the slope of the lower surface of thesclera coupling portion, such that pressure to the limbus is decreasedsubstantially, in accordance with embodiments of the present invention.

FIG. 1B3 shows a tapered edge of the device of FIG. 1B1, in accordancewith embodiments of the present invention.

FIG. 1B4 shows a plan view device having a tricurve profile to fit thecornea, limbus, and sclera with slopes of the curved profiles aligned soas to inhibit ridges at the boundaries of the curved portions, inaccordance with embodiments of the present invention.

FIG. 1B5 shows a side sectional view of the device of FIG. 1B4 andcorresponding curved portions to couple to the cornea, limbus, andsclera, in accordance with embodiments of the present invention.

FIG. 1B6 shows a side sectional view of the device of FIG. 1B4 andcorresponding curved portions of the upper surface, in accordance withembodiments of the present invention.

FIG. 1B7 shows a tapered edge of the device of FIG. 1B4, in accordancewith embodiments of the present invention.

FIG. 1C shows a device comprising a single piece of material having aninner thickness greater than an outer thickness, in accordance withembodiments of the present invention.

FIG. 1C1 shows a device as in FIGS. 1-2A to 1B2 having an inner portioncomprising an inner thickness and an inner material and an outer portioncomprising an outer thickness and an outer material, in which the innerthickness is greater than the outer thickness, in accordance withembodiments of the present invention.

FIG. 1C2 shows a device as in FIGS. 1-2A to 1B2 having an inner portioncomprising an inner thickness and an inner material and an outer portioncomprising an outer thickness and an outer material, in which the innerthickness is greater than the outer thickness and the outer materialextends around the inner material, in accordance with embodiments of thepresent invention.

FIG. 1C2A shows a device as in one or more of FIGS. 1-2A to 1B7 having alayer of silicone or hydrogel material on a posterior surface of thedevice, in accordance with embodiments of the present invention.

FIG. 1C2B shows a device as in one or more of FIGS. 1-2A to 1B7 having alayer of silicone or hydrogel material on a posterior surface of thedevice extending less than a maximum distance across the device suchthat end portions of the device are configured to engage the epitheliumof the eye away from the silicone or hydrogel layer and inhibit movementof the device when placed on the eye, in accordance with embodiments ofthe present invention.

FIG. 1C2C shows a device as in one or more of FIGS. 1-2A to 1B7 havingan annular layer of silicone or hydrogel material on a posterior surfaceof the device such that an inner portion of the device contacts thecornea away from the silicone or hydrogel layer and an outer portion ofthe device contacts the cornea away from the device when placed on theeye, in accordance with embodiments of the present invention.

FIG. 1C3 shows a shows a device having a tricurve profile to fit sclerawith slopes of the curved profiles aligned so as to inhibit ridges atthe boundaries of the curved portions as in FIG. 1B2 and having a layerof silicone or hydrogel material on a lower surface, in accordance withembodiments of the present invention.

FIG. 1C4 shows a plan view device having a tricurve profile to fit thecornea, limbus, and sclera with slopes of the curved profiles aligned soas to inhibit ridges at the boundaries of the curved portions as in FIG.1B4 and having a silicone or hydrogel material on a lower surfaceextending less than a maximum distance across the device to engage theconjunctiva with the device away from the silicone or hydrogel material,in accordance with embodiments of the present invention.

FIG. 105 shows a fenestration having a posterior end covered with alayer of silicone or hydrogel extending along the posterior surface ofthe device, in accordance with embodiments of the present invention.

FIG. 106 shows a fenestration extending through a layer of silicone orhydrogel extending along the posterior surface of the device, inaccordance with embodiments of the present invention.

FIG. 1D shows a device comprising channels extending radially outwardalong a lower surface of the device, in accordance with embodiments.

FIG. 1E shows a device comprising channels extending radially inwardalong a lower or posterior surface of the device, in accordance withembodiments.

FIG. 1F shows a test apparatus to measure deflection of a portion of alens in response to a load, in accordance with embodiments.

FIG. 2A shows a device comprising a contact lens placed on the eye withthe eyelids separated, in accordance with embodiments.

FIG. 2B shows a profile view of the device of FIG. 2A with the eyelidsclosing, in accordance with embodiments.

FIG. 2C shows a front view the device of FIG. 2A with the eyelidsclosing, in accordance with embodiments.

FIG. 2D shows side profile of the device of FIG. 2A with the eyelidsopening, in accordance with embodiments.

FIG. 2E shows a device comprising a contact lens placed on the eye suchthat the device is supported with an inner portion of the cornea and theconjunctiva with the device separated from an outer portion of thecornea so as to define a chamber when the eyelids are separated, inaccordance with embodiments.

FIG. 2F shows a profile view of the device of FIG. 2E with the eyelidsclosing, in accordance with embodiments.

FIG. 2F1 shows a profile view of the device of FIG. 2F with rotation ofthe eye when the lids close such that sliding of the device along theepithelium is inhibited when tear liquid is pumped, in accordance withembodiments.

FIG. 2G shows a profile view of the device of FIG. 2E with the eyelidsopening, in accordance with embodiments.

FIG. 2H shows a profile view of the device of FIG. 2E with the eyelidslocated at an intermediate location such that the chamber comprises anintermediate volume, in accordance with embodiments.

FIG. 2I shows a profile view of the device of FIG. 1C4 placed on the eyewith silicone or hydrogel contacting the eye, in accordance withembodiments.

FIG. 3A shows a device positioned on cornea an eye having an epithelialdefect, in accordance with embodiments.

FIG. 3B shows a device in a first configuration prior to placement oncornea of an eye having an epithelial defect, in accordance withembodiments.

FIG. 3C shows the device of FIG. 3B placed on the eye having a secondconfiguration, in accordance with embodiments.

FIG. 4A shows a mold suitable to form an optical component of a device.

FIG. 4B shows a mold suitable to form a device comprising the opticalcomponent of FIG. 4A.

FIG. 4C shows a mold suitable to form a device comprising the opticalcomponent of FIG. 4A and a layer of a soft material of the device.

FIG. 4D shows a mold to form a device and having a solid inner componentcomprising the rigid material placed therein prior to injection of aflowable material, in accordance with embodiments of the presentinvention.

FIG. 4E shows formation of fenestrations in a device with energy, inaccordance with embodiments of the present invention.

FIG. 4F shows spin coating of a silicone or hydrogel material on aposterior surface of the device, in accordance with embodiments of thepresent invention.

FIG. 4G shows chemical vapor deposition on the device having thesilicone or hydrogel material formed thereon, in accordance withembodiments of the present invention.

FIG. 4H shows a device comprising the silicone or hydrogel materialpackaged in a container, in accordance with embodiments of the presentinvention.

FIG. 5 shows a device in accordance with certain embodiments.

FIG. 6A shows views of radials for an example of a hard lens positionedon an astigmatic eye.

FIG. 6B shows views of radials for an example of a soft lens positionedon an astigmatic eye.

FIG. 6C shows views of radials for an example of a device according tocertain embodiments of the present invention positioned on an astigmaticeye.

FIG. 7 shows a cross-sectional view of an ophthalmic device according tocertain embodiments of the present disclosure.

FIG. 8A shows the average spherical lens corrected visual acuity (LogMAR) for a population of patients having eyes with 1.25DC to 2.00DCuncorrected cylindrical error and wearing an ophthalmic lens provided bythe present disclosure characterized by different thickness of the inneroptical region.

FIG. 8B shows the percent of patients in a population of patients havinga visual acuity of less than 20/25 or less than 20/20 when wearingophthalmic lenses provided by the present disclosure having differentthicknesses and where the patients have eyes with uncorrectedcylindrical error of 1.25DC to 2.00DC.

FIG. 9A shows the average spherical lens corrected visual acuity (LogMAR) for a population of patients having eyes with 2.25DC to 3.00DC ofuncorrected cylindrical error and wearing an ophthalmic lens provided bythe present disclosure characterized by different thickness of the inneroptical region.

FIG. 9B shows the percent of patients in a population of patients havinga visual acuity of less than 20/25 or less than 20/20 when wearingophthalmic lenses provided by the present disclosure having differentthicknesses and where the patients have eyes with uncorrectedcylindrical error of 2.25DC to 3.00DC.

FIG. 10A shows a comparison of the comfort score for patients wearing anophthalmic lens provided by the present disclosure having differentthicknesses of the inner optical portion compared to the comfort scorefor patients wearing commercially available toric contact lenses forastigmatic correction.

FIG. 10B shows histograms of the percent of patients having a comfortscore equal to or greater than 8 and a comfort score equal to or greaterthan 9 after wearing an ophthalmic lens provided by the presentdisclosure with different inner optical region thickness for 30 minutes.

FIG. 11 shows the experimental configuration for measuring flexure ofthe inner portion of an ophthalmic lens according to ISO 18369-4.

FIG. 12 is a graph showing the force (gm) required to flex certainembodiments of an inner portion of an ophthalmic lens provided by thepresent disclosure having different cross-sectional thicknesses.

FIG. 13 is a histogram comparing the force (gm) required to flex aninner portion of ophthalmic lenses provided by the present disclosure by1% with two commercially available lenses used to correct refractiveerror.

FIGS. 14A-14C shows cross-sectional profiles for three examples ofophthalmic lenses provided by the present disclosure.

FIGS. 15A and 15B shows perspective and cross-sectional views,respectively, of an ophthalmic lens for correcting refractive erroraccording to certain embodiments.

FIG. 16 shows fenestrations at various locations of an ophthalmic lensaccording to certain embodiments.

FIG. 17A shows a bimodular contact lens having a center optic portionand a peripheral portion.

FIG. 17B shows the bimodular contact lens of FIG. 17A includingfenestrations positioned on a cornea to form a lenticular volume.

Reference is now made in detail to embodiments provided by the presentdisclosure. The disclosed embodiments are not intended to be limiting ofthe claims.

DETAILED DESCRIPTION

Embodiments of the present invention as described herein can be combinedwith a therapeutic e device for pain management and vision as describedin U.S. Publication No. 2010/0036488, the full disclosure of which isincorporated by reference and is suitable for combination in accordancewith some embodiments of the present invention as described herein.

An ophthalmic device or device encompasses both ophthalmic coverings andophthalmic lenses. As used herein, a covering is used to refer to anophthalmic device that covers an eye of a patient and that does not byitself provide refractive vision correction. Ophthalmic devices thatprovide refractive correction are referred to herein as contact lensesor ophthalmic lenses. A lens may include certain features as disclosedherein for coverings and coverings may include certain features asdisclosed herein for lenses.

Certain embodiments described herein can be used to treat eyes in manyways with a device such as a contact lens. A device described herein canbe used for long term vision correction with extended wear contactlenses that inhibit swelling of the cornea when the device is positionedon the eye for an extended period, and may also be combined with manyforms of ocular surgery, such as photorefractive keratectomy. Certainembodiments of the present disclosure may be use to correct refractiveerror.

As used herein, mathematical equations and scientific notation can beused to identify values in many ways understood by a person of ordinaryskill in the art, for example so as to express data in accordance withnotations used in many commercially available spreadsheets such asExcel™ commercially available from Microsoft. As used herein the symbol“E” can be used to express an exponent in base 10, such that 1E1 equalsabout 10, 2E1 equals about 20, and 4E2 equals about 400. As used hereinthe symbol “̂” can be used to express an exponent, such that ÂB equalsA^(B). Units can be expressed in many ways and as would be understood bya person of ordinary skill in the art, for example “m” as meters, “Pa”as the Pascal unit for pressure, “MPa” as Mega Pascal.

As used herein, a siloxane bond encompasses a covalent —Si—O—Si— bond,for example of a silicone elastomer.

As used herein, an on K fit of a device such as a contact lensencompasses fitting the contact lens to the flattest meridian of thecornea and the on K fit can be flatter than the flattest meridian withinabout 1.5 D. For example, for a cornea having keratometer values(hereinafter “K's”) of about 44D axis 90 and 43D axis 180, the on K fitwould provide a device having a curvature corresponding to an opticalpower within a range from about 43D to about 41.5 D for the region ofthe eye measured. The on K fit as described herein can allow for tearliquid to form under the device such that the tear liquid can be pumpedin accordance with embodiments as described herein.

The optical power of the cornea in Diopters (“D”) can be related to theradius R of curvature of the cornea with the formula D=(1.3375-1)/R,where 1.3375 corresponds to the index of refraction of the aqueoushumora. The curvature of the cornea is inversely related to the radiusof curvature R such that as the radius of curvature increases thecurvature of the cornea decreases and such that as the radius ofcurvature decreases, the curvature of the cornea increases.

As used herein the terms outer portion of a lens and peripheral portionof a lens are used interchangeably. The outer or peripheral portion isdisposed radially around and connected to the inner portion of acovering or lens. In general, the outer or peripheral portion tapersfrom a thickness at the interface with the inner portion toward theouter or peripheral edge of the covering or lens. The outer orperipheral portion may be further characterized by sub-portionscharacterized by, for example, different radii of curvature, thickness,rigidity, and material. The sub-portions may be configured radiallyaround the center optic porition. Furthermore, the outer or peripheralportion is typically disposed outside the optical region of the corneawith the covering or lens centered on the cornea of an eye. The innerportion is also referred to herein as the inner or optical component orbutton. The outer portion is also referred to herein as the outer orcoupling component.

FIG. 1 shows an eye 2 suitable for use with the device 100 (not shown)as described herein. In certain embodiments, device 100 comprises acontact lens. The eye has a cornea 10 and a lens 4 configured to form animage on the retina 5, and the image can form on a fovea 5Fcorresponding to high visual acuity. The cornea can extend to a limbus 6of the eye, and the limbus can connect to a sclera S of the eye. The eye2 has a pars plana PP located near limbus 6. A conjunctiva C of the eyecan be disposed over the sclera. The lens can accommodate to focus on anobject seen by the patient. The eye has an iris 8 that defines a pupil 9that may expand and contract in response to light. The eye alsocomprises a choroid CH disposed the between the sclera 7 and the retina5. The eye has a vitreous humor VH extending between the lens and theretina. The retina 5 senses light of the image and converts the lightimage to neural pulses that are processed and transmitted along an opticnerve ON to the brain of the patient.

FIG. 1-1A shows an ablated eye immediately following refractive surgery,for example PRK surgery resulting in an epithelial defect. The devicecomprising a contact lens as described herein can be placed over theablated cornea and coupled to the conjunctiva to provide improvedvision. The eye 2 comprises an iris 8 that defines a pupil 9, throughwhich light passes such that the patient can see. Cornea 10 includes anepithelium 12 disposed over a stroma 16. The epithelium 12 comprises athickness 12T that can be about 50 μm. A tear liquid covers the anteriorsurface of epithelium 12. In at least humans, primates and some birds, aBowman's membrane 14 is disposed between epithelium 12 and stroma 16.Bowman's membrane 14 comprises an acellular substantially collagenoustissue with a thickness of about 5 to 10 microns. Stroma 16 comprises asubstantially collagenous tissue with keratocytes disposed therein. Insome animals, Bowman's membrane may be absent and the epithelium may bedisposed adjacent to the stromal layer. An endothelium 18 is disposedunder stroma 16. Endothelium 18 comprises a layer of cells that pumpwater from cornea 10 toward iris 8. Tear liquid also covers surfaces ofthe cornea that are exposed by the epithelial defect, such as an exposedsurface of Bowman's membrane and an exposed stromal surface.

With refractive surgery, for example PRK, the epithelium can be removedto ablate a refractive correction into Bowman's membrane 14 and/orstroma 16. An initial profile of the anterior surface of stroma and/orBowman's membrane is ablated to an ablated profile 20 to correct thepatient's vision. The profile of tissue removed to correct vision isdescribed in U.S. Pat. No. 5,163,934, entitled “Photorefractivekeratectomy”, the disclosure of which may be suitable for combination inaccordance with some embodiments of the present invention describedherein. Ablated profile 20 generally comprises an optical zone thatextends across the cornea to correct refractive error of the eye and maycorrect aberrations of the eye, for example wavefront aberrations.Ablated profile 20 is bounded by boundary 20B that may circumscribe theablated profile. The ablation profile 20 comprises a maximum dimensionacross, for example a diameter 20D.

The epithelium may comprise an inner boundary that moves centripetallyinward as indicated by arrows 30.

In certain embodiments as described herein, irregularities of the corneaare decreased when the epithelium regenerates so as to provide one ormore of improved vision or comfort. The devices as described herein canbe configured so as to decrease an effect on vision of cornealirregularities.

FIG. 1A1 shows device 100 positioned on a blinking eye. An upper lid anda lower lid can blink over the eye. Work in relation to embodimentssuggests that the upper lid can exert a downward movement 22A and thatthe lower lid can exert an upper movement 22B on the eye. The downwardmovement 22A can be greater than the upper movement 22B. The wettablecoating material as described herein can decrease force and movementtransferred from the lids to the device so as to inhibit motion of thedevice.

FIG. 1A2 shows the device of FIG. 1A1 that is capable of pumping tearliquid under the device. The device 100 has inner portion 110 and outerportion 120, and fenestrations 100F extending through the thickness ofthe device on the outer portion so as to allow tear liquid TL to movethrough the device, which may comprise a medicament. The medicament maycomprise an anesthetic, an analgesic, or other medication, for example.

The device 100 comprises an optical component 100A and a couplingcomponent 100B. The optical component 100A may comprise an inner portion110 of device 100 and the coupling component 100B may comprise an outerportion 120 of device 100. The optical component 100A comprises rigiditysufficient to resist deformation such that the optical component 100 cancorrection vision of the eye. The optical component 100A may comprise asingle layer of material, or a plurality of layers of materials. Thecoupling component 100B may comprise a rigidity less than opticalcomponent 100A, such that the coupling component can one or more ofdeflect or elastically deform so as to conform to the cornea whencovered with the eyelid. The coupling component 100B may comprise aninner component 100B1 to couple to the optical component, an outerportion 100B3 to couple to the sclera, and an intermediate portion100B2. The intermediate portion 100B2 can extend between the innercomponent 100B1 and the outer component 100B3 so as define a chamberwhen placed on the eye.

The optical component 100A and the coupling component 100B can pump tearliquid to the cornea when the eye closes and opens, for example when theeye blinks. The outer component 100B comprising outer portion 120 maycomprise fenestrations 100F. For example, the intermediate portion 100B2may comprise fenestrations 100F. The outer portion 120 may compriseouter portion 100B3 comprising a sclera coupling portion 130 to contactthe conjunctiva over the sclera and peripheral portion 120P. The scleracoupling portion 130 may comprise a thin flange portion extending to theperipheral portion 120P. The sclera coupling portion may comprise a thinelastic portion capable of elastic deformation when the eye blinks toallow the optical component to move downward. Alternatively or incombination, the outer portion 120 may comprise a rigidity sufficient todeflect when the eye blinks.

FIG. 1A3 shows a schematic illustration of the device of FIGS. 1A1 and1A2 pumping tear liquid when the eye closes, in accordance with certainembodiments of the present invention.

When placed on the eye, the device 100 can define a chamber with thelower surface of the device extending along the cornea, the limbus andconjunctiva over the sclera. When the eyelids are separated, the device100 is held loosely on the eye with slight pressure from the eyelidsextending under the outer portion of the device. When the eye blinks,the lids extend over the outer portion 120 of the device and innerportion 110 so as to exert pressure on the device such that the deviceis urged downward toward the cornea and the volume of the chamber underthe device is decreased. The downward movement of the optical component100A of the inner portion 110 of the device 100 can move the devicedownward so as to pass pumped tear liquid 100TL through thefenestrations, and in certain embodiments the pumped tear liquid 100TLcan pass under the peripheral portion 120P.

FIG. 1A4 shows a schematic illustration of the device of FIGS. 1A1 and1A2 pumping tear liquid when the eye opens, in accordance withembodiments of the present invention.

When the eyelids open, the pressure on the device is decreased, suchthat the device can move away from the cornea and increase the volume ofthe chamber. The movement of the optical portion 100A away from thecornea can draw pumped tear liquid 100TL into the device through thefenestrations, and contact of the peripheral portion 120P and scleracoupling portion 130 with the conjunctiva can inhibit flow of tearliquid under the peripheral portion 120P. In certain embodiments, theperipheral portion 120P and sclera coupling portion 130 can contact theconjunctiva so as to form a seal when the eyelids open and the opticalportion 100A moves away from the cornea.

The fenestrations 100F can be located away from the optical component,for example about 3.5 mm to about 4.5 mm from a center of the opticalcomponent to decrease optical artifacts of the fenestrations 100F.However, the fenestrations may be located within the optical componentwhen of a sufficiently small diameter and sufficiently few so as to notproduce perceptible visual artifacts. The fenestrations may comprise apattern to indicate the orientation of the device 100 on the cornea. Forexample, the upper fenestrations and lower fenestrations may indicate a90 degree axis on the patient and horizontal fenestrations can beprovided to indicate the location of the 180 degree axis on the eye ofthe patient. The fenestrations may comprise additional fenestrations tobe located inferiorly to indicate that the device is not flipped by 180degrees on the patient, for example upside down. The additional inferiorfenestrations may also couple to the rivulet comprising tear liquid thatforms near the lower lid, so as to facilitate pumping of tear liquid.For example, when the eye blinks the lower lid may extend over theinferior fenestrations and the upper lid may extend downward to coupleto the lower rivulet. When the eye opens and the eyelids separate theupper eyelid can draw tear liquid of the rivulet over the upperfenestration and the lower eyelid can move inferiorly so as to pass therivulet over the inferior rivulets.

A device may comprise one or more of many optically clear materials, forexample synthetic materials or natural material such as collagen-basedmaterials, and combinations thereof, such as described in U.S.Publication No. U.S. 2010/0036488. For example, a device may comprise anaturally occurring material, such as collagen-based material.Alternatively or in combination, a device material may comprise a knownsynthetic material, for example hydroxyethyl methacrylate (HEMA)hydrogel, hydrogel, silicone hydrogel, silicone, for example hydratedsilicone and derivatives thereof. For example, the optically clearmaterial may comprise one or more of silicone, silicone hydrogel,silicone comprising resin, silicone comprising silicate, acrylate,collagen, or a combination of any of the foregoing. The cured siliconemay comprise silicone that is two-part, heat-curable and RTV (roomtemperature vulcanized). For example, polydimethyl siloxane such asNuSil, or poly(dimethyl) (diphenyl) siloxane may be used to mold thedevice, for example with less than 10% water content so as to increaseoxygen diffusion through the device. A device may compriseperfluoropolyethers or fluorofocal. The material may comprise, forexample, silicone elastomer having optically clear silicate disposedtherein and a water content of no more than about 10%, for example nomore than about 5%, or no more than about 1%, such that the device has avery high Dk exceeding 150×10⁻¹¹ and in certain embodiments exceeding300×10⁻¹¹, and the silicone lens comprising silicate can be treated toprovide a wettable surface. A device may comprise hydrogel, for examplesilicone hydrogel, or silicone and can be formed with a water contentwithin a range from about 5% to about 35% and a modulus within a rangeor a combination of ranges from about 0.1 MPa to about 40 MPa, such thatthe device conforms at least partially to the anterior surface of thecornea. In certain embodiments, devices provided by the presentdisclosure do not contain water and provide a barrier for the flow offluid across the device. For example, when applied to the cornea,devices minimize or prevent the flow of fluid from the cornea and theflow of fluid such as tea fluid from the outer surface of the device tothe cornea. The devices provide a fluid seal and the material ormaterials forming a device are selected to minimize or prevent moisturetransport across the device thickness.

In certain embodiments, the materials forming devices provided by thepresent disclosure are characterized by a high oxygen permeability (Dk,cm²·mL O₂/sec·mL·mm Hg) such as from 100×10⁻¹¹ to 500×10⁻¹¹, from200×10⁻¹¹ to 500×10⁻¹¹, from 250×10⁻¹¹ to 450×10⁻¹¹, from 300×10⁻¹¹ to400×10⁻¹¹, and in certain embodiments, about 350. In certainembodiments, devices provided by the present disclosure arecharacterized by a high oxygen permeability (Dk) such as at least about250×10¹¹, at least about 300×10¹¹, at least about 350×10¹¹, and incertain embodiments, at least about 400×10⁻¹¹.

A device may comprise silicone or silicone hydrogel having a lowionoporosity. For example, a device may comprise silicone hydrogel orsilicone comprising a low ion permeability, and the range of water canbe from about 5% to about 35%, such that the Dk is 100×10⁻¹¹ or more. Incertain embodiments, the low ion permeability may comprise an IonotonIon Permeability Coefficient of no more than about 0.25×10⁻³ cm²/sec,for example no more than about 0.08×10⁻³ cm²/sec. In certainembodiments, the low ion permeability comprises an Ionoton IonPermeability Coefficient of no more than about 2.6×10⁻⁶ mm²/min, forexample no more than about 1.5×10⁻⁶ mm²/min.

A device 100 may comprise a wettable surface coating 134 disposed on atleast the upper side (anterior surface) of the device, such that thetear film of the patient is smooth over the device and the patient cansee. The wettable surface coating may comprise a lubricious coating forpatient comfort, for example to lubricate the eye when the patientblinks. The wettable coating may comprise a contact angle no more thanabout 80 degrees. For example, the coating may comprise a contact angleno more than about 70 degrees, and the contact angle can be within arange from about 55 to 65 degrees to provide a surface with a smoothtear layer for vision. For example, the wettable coating can be disposedboth an upper surface and a lower surface of the device. The uppersurface may comprise the wettable coating extending over at least theinner portion 110.

A wettable coating 134 may comprise one or more of many materials. Forexample, the wettable coating 134 may comprise polyethylene glycol(PEG), and the PEG coating can be disposed on Parylene™. Alternatively,the wettable coating 134 may comprise a plasma coating, and the plasmacoating may comprise a luminous chemical vapor deposition (LCVD) film.For example, the plasma coating comprises at least one of a hydrocarbon,for example CH₄, O₂ or fluorine containing hydrocarbon, for example CF₄coating. Alternatively or in combination, the wettable coating maycomprise a polyethylene glycol (PEG) coating or2-hydroxyethylmethacrylate (HEMA). For example, the wettable coating maycomprise HEMA disposed on a Parylene™ coating, or the wettable coatingmay comprise N-vinylpyrrolidone (NVP) disposed on a Parylene™ coating.

The device 100 may comprise a base radius R1 of curvature correspondingto a curvature of a central portion of the cornea. The device 100comprises a first configuration 100C1 when placed on the cornea and theeyelids are spaced apart and a second configuration 100C2 when placed onthe cornea and the blinks such that the eyelids. The first configuration100C1 and the second configuration 100C2 pump tear liquid under thedevice 100.

The device 100 may comprise a lower surface corresponding to one or moreof many suitable shapes to fit the device to the cornea, such as anatural unablated cornea or an ablated cornea following refractivesurgery such as PRK. The lower surface of the inner portion 110 of thedevice 100 may correspond to base radius of curvature. Withpost-ablation corneas, the device can resist deformation and smooth theepithelium over about 3 mm and may deflect so as conform substantiallyto the ablated cornea over a larger dimension such as 6 mm. The devicemay comprise a second curve in combination with a first curve, such thatthe lower surface comprises a bicurve surface. Alternatively, the lowersurface may correspond to an aspheric surface. For example an asphericsurface may comprise an oblate shape and conic constant to fit a postPRK eye. The curved and aspheric surfaces as described herein can fitnon-ablated eyes and the device can be selected by based on thecurvature of an un-ablated central region of the cornea. Also, it may behelpful to identity a device that fits the cornea, for example withselection of one device from a plurality of sizes.

A device 100 may comprise an inner portion 110 having an opticalcomponent 1 100A. The optical component 100A may comprise an innerportion 110 of the device 100. The optical component may have a moduluswithin a range from about 5 MPa to about 40 MPa, and a thickness withina range from about 100 μm to about 300 μm such that the central portioncan have sufficient rigidity to resist deformation and smoothirregularities and correct vision. A device may comprise an elastomericstretchable material such that the device can stretch to fit the cornea,for example. A device having the modulus within a range from about 4 MPato about 40 MPa can be formed in many ways as described herein. Forexample, the device may comprise a single piece of material having anon-uniform thickness extending across the cornea. A device can beshaped in many ways and may comprise a single piece of one material, ormay comprise a single piece composed of two similar materials, or maycomprise a plurality of materials joined together.

FIG. 1B1 shows device 100 having a tricurve profile to fit a sclera andcornea. The tricurve profile can be used to fit an unablated naturaleye, in which the base curvature R1 corresponds to the optically usedcentral portion of the cornea. For ablated corneas, the base curvatureR1 may correspond to the ablated cornea. The tricurve device maycomprise an inner portion with an inner lower surface having radius ofcurvature R1 and an outer portion comprising an outer lower surfacehaving radius of curvature R1B. The outer portion 130 may comprise thesclera coupling portion 130 having a third radius of curvature R1C sizedto fit the conjunctiva located over the sclera and contact theconjunctiva so as to inhibit sliding movement of inner portion 110. Workin relation to embodiments suggests that coupling to the sclera mayimprove alignment of the lens on the cornea.

The device 100 having the tricurve profile may comprise dimensions sizedto fit the cornea and sclera of the eye 2. The device 100 having the atleast a tricurve profile may comprise an inner portion 110 and an outerportion 120 as described herein. The outer portion 120 may comprise thethird sclera coupling portion 130 having curvature R1C shaped to fit thesclera of the eye, for example shaped so as to contact the conjunctivaof the eye such that the conjunctiva is located between the sclera andthe sclera coupling portion 130. The inner portion 110 may comprise adimension 102 and the outer portion 120 may comprise a dimension 104 asdescribed herein. The device 100 may comprise a sag height 105 extendingbetween an upper location of the inner portion 110 and the outerboundary of outer portion 120 shaped to fit the cornea. The scleracoupling portion 130 may comprise a dimension across 103.

The dimension 102, the dimension 104, the dimension 103, the dimension105 and the dimension 105S can be sized to the eye based on measurementsof the eye. The dimension 103 may correspond to an annular region of thesclera extending from the limbus to the outer boundary of the scleracoupling portion across a distance within a range from about 1 to 4 mm,for example within a range from about 1.5 to 2 mm. The size of thelimbus of the eye can be measured so as to correspond to dimension 104,for example, and can be within a range from about 11 to 13 mm. Thedimension 105 may correspond to a height of the eye from the vertex ofthe cornea to the limbus, and the dimension 105S may correspond to thesag height were the outer location of the device couples to theconjunctiva device the sclera.

The dimension 102 may correspond to an inner region of the naturalcornea or the dimension across an ablation. Dimension 102 may correspondto the more rigid inner portion 110 can be sized about 0.5 to about 2 mmless than the dimension across the ablation zone, such that the soft andless rigid outer portion 120 contacts the eye near the edge of theablation and the epithelial debridement.

The radius of curvature R1C of portion 130 can be determined so as tofit the eye, and can be within a range from about 12 mm±3 mm. The radiusR1B of the outer portion can be fit to within about ±0.5 mm, for exampleto within about ±0.25 mm.

The dimensions of the device 100 can be determined in many ways, forexample with topography measurements of the cornea and sclera. Thecorneal and scleral topography can be measured with many instruments,such as with the Orbscan™ topography system commercially available fromBausch and Lomb, and the Pentacam™ Scheimpflug camera systemcommercially available from Oculus, and commercially available opticalcoherence tomography (OCT). The ablation profile can be combined withthe topography to determine the shape of the eye.

The dimensions of device 100 can be sized to one or more of the corneaand sclera based on tolerances that may be determined clinically.

The outer portion 120 and sclera coupling portion 130 may comprise asilicone or hydrogel material, for example a silicone or siliconehydrogel material, and the inner portion 110 may comprise the rigidmaterial 110M, for example second layer 110L2 and second material 110M2between first layer 110L1 of first material 110M1 and third layer 110L3of third material 110M3 as described herein.

The portions of devices as described herein, for example the innerportion and the outer portion, may comprise a junction wherein a firstportion connects with a second portion, and the junction may have themodulus as described herein. A device may comprise a contact lens havinga central lens portion having a center stiffness of at least about 2psi-mm² coupled to an outer lenticular junction portion having alenticular junction stiffness of at least about 5 psi-mm².

FIG. 1B2 shows device 100 having a tricurve profile to fit sclera withslopes of the curved profiles aligned so as to inhibit ridges at theboundaries of the curved portions, in accordance with embodiments of thepresent invention. An inner portion 110 comprises the optical component100A and the outer portion 120 comprises the coupling component 100B. Acoupling component 100B may comprise a thin layer of material 120Mextending under the optical component 100A for improved comfort andsupport of the optical component. An outer portion 120 comprisingcoupling component 100B may comprise fenestrations 100F as describedherein. An inner portion 120 comprises first radius R1 along the lowersurface and a first anterior radius R1A along the upper surface. Anouter portion 120 couples to the inner portion with a second radius R1Baligned with the first radius R1A at a boundary corresponding todimension 102. The outer portion 120 has a second anterior radius R1BAextending along the anterior surface. The outer portion 120 comprisingsecond radius R1B along the lower surface to contact the cornea maycouple to sclera coupling portion 130 at a location corresponding to thelimbus of the eye, for example along a boundary corresponding todimension 104. Work in relation to embodiments suggests that formationof a ridge near the boundary of the cornea contacting portion and scleracoupling portion may decrease epithelial cell migration somewhat morethan would be ideal, and the alignment of the curved profiles to inhibitridge formation can provide a smooth transition over the limbus and maydecrease mechanical pressure to the limbus. The sclera contactingportion 130 comprises an upper surface having an anterior radius ofcurvature RICA.

The inner portion 110 can be curved to fit an ablated eye or anon-ablated eye. The modulus and thickness of the sclera couplingportion can be configured in many ways to fit may eyes with comfort andso as to resist movement of the inner portion 120. The modulus of scleracoupling portion 130 may be no more than about 5 MPa and the thicknessno more than about 200 μm, for example no more than 100 μm, so as tostretch substantially for comfort and resist movement of the innerportion when the placed on the sclera.

The dimension 103 of sclera coupling portion 130 may correspond to anannular region of the sclera extending from the limbus to the outerboundary of the sclera coupling portion across a distance within a rangefrom about 1 to 4 mm, such that the dimension 103 can be from about 12mm to about 16 mm, for example from about 14 mm to about 16 mm.

The radius of curvature R1C, thickness and modulus of the portion 130can be configured so as to fit the eye to resist movement of innerportion 110 and with comfort. The radius of curvature R1C can be sizedless than the radius of curvature of the sclera and conjunctiva. Forexample, the radius of curvature R1C can be no more than about 10 mm,for example no more than about 9 mm when the curvature of the scleraportion of the eye is at least about 12 mm for example. The thirdrelative rigidity may comprise no more than about 4E-5 Pa-m³ so as tostretch substantially for comfort and resist movement of the innerportion when the outer portion is placed on the sclera.

The thickness of the sclera coupling portion having radius of curvatureR1C can vary, for example from a thickness of about 100 μm to a taperededge.

FIG. 1B2-1 shows alignment of the slope of the lower surface of thecorneal contacting portion comprising second radius R1B with the slopeof the lower surface of the sclera coupling portion 130 comprisingradius R1C, such that pressure to the limbus is decreased substantially.The second slope corresponding to second radius R1B is given by a heightR1BY and a length R1BX, and the third slope corresponding to thirdradius R1C is given by height R1CY and width R1CX. The second slope isaligned with the third slope such that no substantial ridge is formed atthe location corresponding to the limbus. For example, the first slopecan be substantially equal to the second slope. The slope of the innerportion 110 can be aligned with the slope of the second portion 120 at alocation corresponding to dimension 102 in a similar manner.

FIG. 1B3 shows a tapered edge of the device of FIG. 1B1 having atricurve profile to fit sclera and cornea. The sclera coupling portion130 may comprise a flange 120F having a narrowing taper extending adistance 120FW to a chamfer 120FE. The chamfer 120FE can be definedalong an outer rim where a first convexly curved lower surface joins asecond convexly curved upper surface. The convex surfaces along theouter rim allow the device to slide along the conjunctiva and thenarrowing taper permits the sclera coupling portion of the device tostretch substantially and couple to the sclera and conjunctiva withdecreased resistance for comfort.

The dimensions of the device 100 can be determined in many ways, forexample with one or more topography measurements or tomographymeasurements of the cornea and sclera. The corneal and sclera topographycan be measured with many instruments, such as with the Orbscan™topography system commercially available from Bausch and Lomb, and thePentacam™ Scheimpflug camera system commercially available from Oculus.The tomography can be measured with optical coherence tomography(hereinafter “OCT”) so as to determine the sag height of the limbus andconjunctiva, for example with OCT measurement systems commerciallyavailable from Zeiss/Humphrey. The ablation profile can be combined withthe topography to determine the shape of the eye.

FIG. 1B4 shows a plan view device 100 having a multi-curve profile tofit the cornea, limbus and sclera with slopes of the curved profilesaligned so as to inhibit ridges at the boundaries of the curvedportions, in accordance with embodiments of the present invention. Thedevice 100 comprises fenestrations 100F and optical component 100A forvision correction and outer coupling component 100B that may pump tearliquid as described herein.

FIG. 1B5 shows a side sectional view of the device of FIG. 1B4 andcorresponding curved portions to couple to the cornea, limbus, andsclera, in accordance with embodiments of the present invention.

The inner portion 110 comprises optical component 100A, which maycomprise material 110M. The outer portion 120 comprises couplingcomponent 100B, which may comprise outer material 120M. The innerportion 110 is coupled to the outer portion along a boundarycorresponding to dimension 102. The lower surface of inner portion 110has a shape profile corresponding to a first radius R1. The outerportion 120 couples to the inner portion with a first outer radius R1B1of curvature, such that the slopes are aligned as described herein at alocation corresponding to dimension 102. The outer portion 120 comprisesa second outer radius R1B2 of curvature coupled to the first outerradius of curvature R1B1. The first outer radius R1B1 of curvature iscoupled to the second outer radius R1B2 of curvature with the slopesaligned as described herein at a location corresponding to dimension104A. The outer portion 120 comprises a third outer radius R1B3 ofcurvature coupled to the second outer radius of curvature R1B2. Thesecond outer radius R1B2 of curvature is coupled to the third outerradius R1B3 of curvature with the slopes aligned as described herein ata location corresponding to dimension 104B.

The first outer radius of curvature R1B1, the second outer radius ofcurvature R1B2, and the third outer radius of curvature R1B3 maycomprise values determined from a patient population. The first radiusof curvature R1 may comprise a value determined based on the patientpopulation. Alternatively or in combination, the first radius ofcurvature R1 may correspond to a post ablation profile.

The first outer radius of curvature R1B1, the second outer radius ofcurvature R1B2, and the third outer radius of curvature R1B3 can becombined or replaced with an aspheric surface such as a conic surface.The conic surface can be determined in accordance with the first outerradius of curvature R1B1, the second outer radius of curvature R1B2, andthe third outer radius of curvature R1B3, such that the conic surfacecorresponds to values determined from a patient population.

The sclera coupling portion 130 may have a lower surface comprising afirst sclera coupling radius R1C1 of curvature and a second scleracoupling portion having a second sclera coupling radius R1C2 ofcurvature. The first sclera coupling portion comprising radius R1C1 canbe aligned to the third radius R1B3 at a location corresponding todimension 104. The second sclera coupling portion comprising radius R1C2can be aligned to the first sclera coupling portion having radius R1C1at a location corresponding to dimension 120FW corresponding to an innerboundary of tapering flange 120F.

FIG. 1B6 shows a profile view of the device of FIG. 1B4 andcorresponding curved portions of the upper surface, in accordance withembodiments of the present invention. The upper surface may comprise aninner anterior radius of curvature R1A, a first outer anterior radius ofcurvature R1B1A, a second outer anterior radius of curvature R1B2A. Thesclera coupling portion 130 may comprise a first anterior radius R1C1Aof curvature and a second anterior coupling radius R1C2A of curvature.

FIG. 1B7 shows a tapered edge of the device of FIG. 1B4, in accordancewith embodiments of the present invention.

FIG. 1C shows device 100 comprising a device molded with a homogeneousmaterial, in which the outer portion comprises a thickness configured toconform to the surface of the cornea and in which the inner portion 110comprises thickness configured to smooth the epithelium and cornea. Theinner portion 110 comprises optical component 100A, and the outerportion 120 comprises coupling component 100B. The inner portion 110 maycomprise a thickness of no more than about 300 microns, for example nomore than about 200 microns. Many materials can be used as describedherein, and the device may comprise one or more materials. For example,the device may comprise a single piece of material such as siliconehaving a water content within a range from about 0.1% to about 10%, forexample no more than about 1%, and a hardness Shore A durometerparameter within a range from about 5 to about 90, for example within arange from about 40 to about 85.

FIG. 1C1 shows a device 100 having an inner portion 110 comprising aninner thickness and an inner material 110M and an outer portion 120comprising an outer thickness and an outer material 120M, in which theinner thickness is greater than the outer thickness. The inner material110M may comprise many materials and may comprise an optically clearsilicone, for example silicone with resin. The inner material maycomprise silicone positioned in a mold with the outer portion 120 formedaround the inner portion. The inner portion may comprise a hardnesssimilar to the outer portion. The outer material 120M of the outerportion 120 may comprise a material similar to the inner portion. Forexample the outer material 120M may comprise silicone and the innermaterial 110M may comprise silicone. This use of similar materials onthe inner and outer portion can improve adhesion of the inner portion tothe outer portion. The outer material 120M may extend along the innerportion 110, for example along the underside of the inner portion 110,such that the inner material 110M is held in a pocket of the outermaterial 120M. Alternatively, the inner material 110M may extendsubstantially across the thickness of the inner portion 110, such thatthe outer material 120M comprises a substantially annular shape with theinner material 110M comprising a disc shaped portion disposed within theannulus and extending substantially from the upper surface coating tothe lower surface coating when present.

FIG. 1C2 shows device 100 having inner portion 110 comprising an innerthickness and inner material 110M and outer portion 120 comprising anouter thickness and outer material 120M, in which the inner thicknesscan be greater than the outer thickness and the outer material 120Mextends around the inner material 110M. The inner portion 110 comprisesthe optical component 100A and the outer portion 120 comprises thecoupling component 100B. The device 100 may comprise at least a bicurvedevice having at least a second radius R1B. The inner portion 110M maycomprise three layers of material, a first layer 110L1 of a firstmaterial 110M1, a second layer 110L2 of a second material 110M2 and athird layer 110L3 of a third material 110M3. The second material 110M2may comprise a rigid material, for example one or more of a rigid gaspermeable material, a rigid silicone, or a rigid silicone acrylate. Thefirst material 110M1 and the third material 110M3 may comprise a softmaterial, for example a soft elastomer, soft hydrogel, or soft siliconesuch as one or more of a soft optically clear silicone or a softsilicone hydrogel. The first material, the third material, and the outermaterial 120M may comprise similar materials, such that the second layerof rigid material 110M2 is encapsulated with the first soft material110M1, the third soft material 110M3 and on the perimeter with the softouter material 120M. In certain embodiments, the second rigid material110M2 comprises a material similar to each of the first material 110M1,the third material 110M3 and the outer material 120M, for example eachmay comprise silicone, such that the corresponding portions of thedevice 100 can be bonded together with the silicone similar siliconeelastomer material, for example. In certain embodiments, the device 100can be formed in a mold with rigid second material 110M2 placed in themold and encapsulated within a single piece of material comprising firstmaterial 110M1, third material 110M3 and outer material 120M, such thatfirst material 110M1, third material 110M3 and outer material 120Mcomprise substantially the same material, for example siliconeelastomer. The rigid second material 110M2 may comprise silicone bondedto each of first material 110M1, third material 110M3 and the outermaterial 120M, for example with curing such that first material 110M1,third material 110M3 and outer material 120M comprise the same softsilicone material bonded to the second material 110M2 comprising rigidsilicone.

The soft material comprising soft outer portion 120 composed of softmaterial 120M, first layer 110L1 composed of soft material 110M1 andthird layer 110L3 composed of soft material 120M3 can provide improvedcomfort and healing for the patient, and can extend the amount of timethe device can be worn in the eye when combined with the fenestrations100F and sclera coupling component 130 and peripheral portion 120P andflange 120F as described herein. The soft material can deflect, bend orindent so as to conform at least partially to the tissue of the eye whenthe rigid portion comprising rigid material 110M2 corrects vision of thepatient. The dimension 102 across inner portion 110 can be sized tosubstantially cover one or more of the entrance pupil of the eye orablation zone. With ablated eyes, the dimension 102 can be sizedslightly smaller than the ablation dimensions, such as ablation diameter20D, so that the epithelium can grow inward and contact the layer 110L1of soft first material 110M1 without substantial disruption from therigid material 120M2 when the inner portion 110M corrects vision withthe layer of rigid material 110M2. The eyelid can also move over thethird layer 110M3 for improved comfort. The soft first material 110M1and soft third material 110M3 may comprise soft elastomer, softhydrogel, or soft silicone, for example, and may each comprise the samematerial so as to encapsulate the second layer 110L2 of rigid secondmaterial 110M2.

The soft material comprising soft outer portion 120 composed of softmaterial 120M, first layer 110L1 composed of soft material 110M1 andthird layer 110L3 composed of soft material 120M3 can have a moduluswithin a range from about 1 to 20 MPa, for example within a range fromabout 1 to 5 MPa.

The material inner material 120M and 120M2 of second layer 120L2 canhave a modulus within a range from about 5 MPa to about 35 MPa or more,for example as set forth in Table A below. For example, when material120M comprises silicone elastomer or layer 110L2 of material 120M2comprises silicone elastomer, the modulus can be within a range fromabout 5 MPa to about 35 MPa, for example within a range from about 20MPa to about 35 MPa.

The layers of device 100 can comprise dimensions so as to providetherapeutic benefit when placed on eye 2. The thickness of layer 110L1can be from about 5 μm to about 50 μm, for example, within a range fromabout 10 μm to 30 μm, such that the layer 110L1 can provide a soft atleast partially conformable material to receive the lens. The middlelayer 110L2 can be from about 20 μm to about 150 μm, for example, andmaterial M2 can have a modulus greater than first material 110M1 offirst layer 110L1, so as to deflect the epithelium of the eye when themiddle layer is deflected. The third layer 110L3 can be within a rangefrom about 5 μm to 50 μm, for example within a range from about 10 μm toabout 30 μm, and can cover second layer 110L2 so as to retain the secondlayer in the inner portion 110 of the device 100.

The therapeutic device 100 may comprise a first inner material 110M anda second outer material 120M, in which the outer portion 120 comprises ahardness configured to stretch elastically and conform with one or moreof epithelium of the cornea or the conjunctiva, and in which the innerportion 110 comprises second hardness configured to smooth the cornea toprovide optical benefit. The outer material 120M may comprise manymaterials as herein. The Shore A hardness of each of the inner portionand the outer portion can be within a range from about 5 to about 90.For example, the outer material 120M may comprise silicone having ahardness Shore A durometer from about 20 to about 50, for example fromabout 20 to about 40, and the inner material 110M may comprise siliconehaving a Shore A hardness from about 40 to about 90, for example fromabout 50 to about 90. The outer portion comprises a perimeter 120P, andthe perimeter may comprise a peripheral and circumferential edgestructure to abut the epithelium to form a seal with the epithelium, forexample when the base radius of the device is less than the cornea. Theperipheral and circumferential edge structure can be shaped in many waysto define an edge extending around the perimeter to abut the epithelium,for example with one or more of a taper of the edge portion extending tothe perimeter, a bevel of the edge portion extending to the perimeter ora chamfer of the edge portion extending to the perimeter. The innerportion 110 may comprise inner thickness and inner material 110M and theouter portion 120 may comprise an outer thickness and outer material120M, in which the inner thickness is substantially similar to the outerthickness.

The peripheral edge structure to abut the epithelium can be used withmany configurations of the inner portion as described herein. Forexample, the inner portion may comprise an RGP lens material having alower rigid surface to contact and smooth the cornea and an upper rigidoptical surface. Alternatively, the inner portion may conform to thecornea as described herein. The outer portion may comprise a skirt, andthe skirt may comprise the peripheral edge structure to abut and sealthe cornea, such as the chamfer. The rigidity of the outer portioncomprising the edge structure can be determined to seal the cornea withone or more of hardness and thickness, as described herein.

FIG. 1C2A shows a device as in one or more of FIGS. 1-2A to 1B7 having alayer of silicone or hydrogel material on a posterior surface of thedevice. The device 100 may comprise a wettable surface coating 134disposed on at least the upper side of the device as described herein.The layer of silicone or hydrogel material may comprise an inner portionof the layer of silicone or hydrogel material 110MHG and an outerportion of the layer of silicone or hydrogel material 120MHG. The layerof silicone or hydrogel material extends to the fenestration so as tocouple the silicone or hydrogel material to the fenestration. Thesilicone or hydrogel material can be coupled to the fenestration in manyways. For example, the layer of silicone or hydrogel material may coverthe fenestration, or the fenestration 100F may extend through thesilicone or hydrogel material. The fenestration 100F extending throughthe layer of silicone or hydrogel material can encourage pumping of thetear liquid as described herein. Alternatively or in combination, thelayer of silicone or hydrogel material device a posterior surface of thefenestration 100F to couple the fenestration 100F to the silicone orhydrogel layer may encourage movement of a therapeutic agent along thesilicone or hydrogel layer toward a central portion of the cornea forexample. The silicone or hydrogel may extend along a deflectable portionof the device so as to exert at least some pressure on the silicone orhydrogel layer to encourage movement of one or more of tear liquid orthe therapeutic agent along the silicone or hydrogel layer when thepatient blinks, for example.

The silicone or hydrogel layer as described herein may encourageregeneration of the epithelium and may provide a soft surface to contactthe epithelium regenerating over the ablation so as to encourageepithelial regeneration under the optical component as described herein,and the optical component can resist deformation so as to protect theepithelium and provide an environment to encourage regeneration of theepithelium.

The silicone or hydrogel material may comprise one or more of thesilicone or hydrogel materials as described herein. The silicone orhydrogel material extending along the lower surface can increase comfortof the device when placed on the eye. The silicone or hydrogel materialmay comprise a substantially uniform thickness within a range from about1 μm to about 100 μm, for example from about 2 μm to about 50 μm and incertain embodiments within a range from about 5 μm to about 20 μm. Thesilicone or hydrogel material extending along the posterior surface maycomprise one or more of the silicone or hydrogel materials as describedherein combined with one or more of materials 110M, 110M1, 110M2, 110M3or 120M as described herein. For example the one or more of materials110M, 110M1, 110M2, 110M3 or 120M may comprise silicone such as siliconeelastomer comprising siloxane, and the silicone or hydrogel may comprisea silicone or hydrogel such as silicone or hydrogel material asdescribed herein.

FIG. 1C2B shows a device as in one or more of FIGS. 1-2A to 1B7 having alayer of hydrogel material on a posterior surface of the deviceextending less than a maximum distance across the device such that endportions of the device are configured to engage the epithelium of theeye away from the hydrogel layer and inhibit movement of the device whenplaced on the eye. In certain embodiments, the material 120M can coupleto the surface of the eye, for example the epithelium so as to inhibitmovement of the device. The material 120M may comprise a sticky tackyhydrophobic material such as silicone to engage the epithelium toinhibit movement, and the material 120M may be coated with one or morecoatings as described herein, for example with vapor deposition. Thesilicone or hydrogel material can be coupled to the fenestration in manyways. For example, the layer of silicone or hydrogel material may coverthe fenestration, or the fenestration 100F may extend through thesilicone or hydrogel material.

FIG. 1C2C shows a device 100 as in one or more of FIGS. 1-2A to 1B7having an annular layer of silicone or hydrogel material 120MHG on aposterior surface of the device such that an inner portion of the devicecontacts the cornea away from the silicone or hydrogel layer and anouter portion of the device contacts the cornea away from the devicewhen placed on the eye. Work in relation to embodiments suggests thatthe annular silicone or hydrogel layer can provide an environment toencourage growth of the epithelium along the posterior surface of innermaterial 110M1 as described herein, and the lower surface of material110M1 can be coated with a material having a thickness less than thesilicone or hydrogel, for example.

FIG. 1C3 shows a device having a tricurve profile to fit sclera withslopes of the curved profiles aligned so as to inhibit ridges at theboundaries of the curved portions as in FIG. 1B2 and having a layer ofsilicone or hydrogel material 120MHG on a lower surface. The silicone orhydrogel material 120M may extend substantially across the posteriorsurface of the device. A silicone or hydrogel material may extend alongthe lower surface a distance less than a distance across the device soas to provide a portion of the device without the silicone or hydrogelto engage the eye, for example the epithelium of the eye that maycomprise one or more of the corneal epithelium or the conjunctivalepithelium. Alternatively, a silicone or hydrogel material may extendsubstantially along the posterior surface of the device corresponding tothe distance across the device so as to provide a portion of the devicewith a silicone or hydrogel material over the outer portion of thedevice that engages the eye.

FIG. 1C4 shows a plan view of a device having a tricurve profile to fitthe cornea, limbus, and sclera with slopes of the curved profilesaligned so as to inhibit ridges at the boundaries of the curved portionsas in FIG. 1B4 and having a silicone or hydrogel material on a lowersurface extending less than a maximum distance across the device toengage the conjunctiva with the device away from the silicone orhydrogel material. Alternatively, the silicone or hydrogel material mayextend substantially along the posterior surface of the devicecorresponding to the distance across the device so as to provide thesilicone or hydrogel material over the outer portion of the device thatengages the eye. The silicone or hydrogel device may comprise an annularshape extending along the lower surface as described herein.

FIG. 105 shows a fenestration 100F having a posterior end 100FPE coveredwith a layer of silicone or hydrogel material 29MHG extending along theposterior surface of the device 100, in accordance with embodiments ofthe present invention.

FIG. 106 shows fenestration 100F extending through a layer of siliconeor hydrogel material 120MHG extending along the posterior surface of thedevice 100, in accordance with embodiments of the present invention.

FIG. 1D shows a device comprising channels 100FC extending radiallyoutward from fenestrations 100F along a lower surface of the device, inaccordance with embodiments.

FIG. 1E shows a device comprising 100FC channels extending radiallyinward from fenestrations 100F along a lower surface of the device, inaccordance with embodiments.

FIG. 1F shows a test apparatus 190 to measure deflection of a portion ofa lens in response to a load. The load deflection of the devices andcomposite layers as described herein can be used to determine thedeflection of the device and corresponding pumping. Work in relation toembodiments suggests that one or more of the inner device or the outerdevice contacting the epithelium may comprise a rigidity such thatblinking of the eye deflects the device sufficiently with elasticdeformation so as to urge tear liquid from beneath the device asdescribed herein. For example, the inner portion 120 of the devicessuited to cover the ablated cornea and provide pumping as describedherein are also well suited to cover natural unablated corneas toprovide vision correction with pumping of the tear liquid. The outerportion 120 may comprise a rigidity as described herein sufficient todeflect when the eye blinks and provide elastic deformation that maypump tear liquid under the device such as a contact lens.

The test apparatus 190 may comprise a rigid support having an aperture192, such that deflection of the device 100 through the aperture 192 canbe measured. The aperture 192 has a dimension across 194 that can besized smaller than the dimension across inner portion 110, so as tomeasure a deflection 110D of the inner portion 110 in response to a load196. The deflection 110D may comprise a peak deflection, for example adistance. The load 196 may comprise a point load or a load distributedover an area corresponding to diameter 104, for example a pressure froma gas or liquid on the lower side of the device. The device may comprisea first configuration C1 corresponding to the shape of the device priorto placement on the eye, and the device may comprise a secondconfiguration C2 when placed on the eye, and the amount of force and/orpressure to deflect device 100 can be determined such that device 100can be deflected without substantially degrading vision and so as tosmooth the epithelium. For example, the device may deflect slightly soas to decrease vision no more than about 1 or 2 lines of visual acuityand such that the device can smooth the epithelium and provideenvironment 100E as described herein.

The modulus and thickness of the device can be used to determine anamount of relative rigidity of the device 100, the corresponding amountof force to deflect the device 100 across a distance, and thecorresponding amount pressure to smooth the epithelium with thedeflected device as described herein.

The amount of relative rigidity can be determined based on the modulusmultiplied with cube of the thickness. The amount of deflectioncorresponds to the sixth power of the deflected span across the device,the modulus, and the cube of the thickness. The approximately fourthorder relationship of the span to the deflection can allow the devicesas described herein to conform at least partially to the ablationprofile within a range from about 4 mm to 6 mm, and inhibitsubstantially irregularities having diameters of about 3 mm or less, forexample.

The deflection can be approximated with the following equation:

Deflection≈(constant)×(Load×Span⁴)/(Modulus×thickness³)

The above approximation can be useful to understand the properties ofdevice 100, for example with a substantially uniform thickness of theinner portion. The substantially uniform thickness may comprise athickness that is uniform to within about ±25%, for example to withinabout ±10%, such that the device can conform substantially to at least amajority of the surface area of an ablation zone and inhibitirregularities over a smaller portion of the ablation zone correspondingto no more than a minority of the surface area of the ablation. Incertain embodiments, a device conforms over an area having diameter ofat least about 4 mm and inhibits irregularities over an area having adiameter of no more than about 4 mm, for example less inhibitsirregularities over an area of no more than about 3 mm. For example,based on the above equations, the deflection is related to the fourthpower of the span, such that for a comparable load, a 2 mm span willhave about 1/16^(h) the deflection of a 4 mm span. Similarly, a 3 mmspan will have a deflection that is about 1/16^(h) the deflection of a 6mm span. As the deflection is related to the cube of the thickness,doubling the thickness can decrease the deflection by about a factor of8. The above approximations can be combined with clinical testing todetermine thicknesses and moduli suitable for incorporation inaccordance with embodiments as described herein.

The equations for deflection of an unsupported circular span of amaterial having a substantially uniform thickness are:

$E_{c} = {{E_{1}\left( \frac{t_{1}}{t_{1} + t_{2}} \right)} + {E_{2}\left( \frac{t_{2}}{t_{1} + t_{2}} \right)}}$${{``{Relative}"}\mspace{14mu} {Rigidity}} = {E_{c}\left( {t_{1} + t_{2}} \right)}^{3}$$y = {\frac{3{wR}^{4}}{16{Et}^{3}}\left( {5 + v} \right)\left( {1 - v} \right)}$$w = \frac{y\; 16{Et}^{3}}{\left( {5 + v} \right)\left( {1 - v} \right)3R^{4}}$

where:W=evenly distributed load over the surface, Pressure (Pa);R=span of unsupported material (m);

E=Young's Modulus (Pa);

t=Thickness (m);v=Poisson's Ratio (unit-less, assumed to be constant among materials);andy=Deflection (m).

The equations for deflection are described in Theory and analysis ofelastic plates, Junuthula Narasimha Reddy, p. 201 equation 5.3.43(1999).

Although the above equations describe relative rigidity for asubstantially flat surface, the equations can approximate a curvedsurface and a person of ordinary skill in the art can determine thedeflection load and relative rigidity empirically based on the teachingsdescribed herein, for example with finite element modeling.

TABLE A1 Material, modulus, thickness, relative rigidity Dk/anddeflection load of inner portions of coverings as described herein.Uniform Button Button Flexural Flexural Relative Material ButtonThickness Thickness Modulus Modulus Rigidity Dk Dk/t Material (μm) (m)(MPa) (Pa) (Pa*m{circumflex over ( )}3) (×10⁻¹¹) (×10⁻⁹) Rigid 2502.50.E−04 35 35000000 5.47E−04 600 240 Silicone Rigid 200 2.00.E−04 3535000000 2.80E−04 600 300 Silicone Rigid 150 1.50.E−04 35 350000001.18E−04 600 400 Silicone Rigid 100 1.00.E−04 35 35000000 3.50E−05 600600 Silicone Rigid 50 5.00.E−05 35 35000000 4.38E−06 600 1200 SiliconeExemplary 293 2.93.E−04 20 20000000 5.03E−04 600 205 Silicone Exemplary272 2.72.E−04 20 20000000 4.02E−04 600 221 Silicone Exemplary 2502.50.E−04 20 20000000 3.13E−04 600 240 Silicone Exemplary 215 2.15.E−0420 20000000 1.99E−04 600 279 Silicone Exemplary 200 2.00.E−04 2020000000 1.60E−04 600 300 Silicone Exemplary 175 1.75.E−04 20 200000001.07E−04 600 343 Silicone Exemplary 150 1.50.E−04 20 20000000 6.75E−05600 400 Silicone Exemplary 100 1.00.E−04 20 20000000 2.00E−05 600 600Silicone Exemplary 50 5.00.E−05 20 20000000 2.50E−06 600 1200 Materialenflufocon A 25 2.50.E−05 1900 1900000000 2.97E−05 18 72 (Boston ES)enflufocon A 50 5.00.E−05 1900 1900000000 2.38E−04 18 36 enflufocon A150 1.50.E−04 1900 1900000000 6.41E−03 18 12 hexafocon B 25 2.50.E−051160 1160000000 1.81E−05 141 564 (Boston XO2) hexafocon B 50 5.00.E−051160 1160000000 1.45E−04 141 282 hexafocon B 150 1.50.E−04 11601160000000 3.92E−03 141 94

As shown in Table A1, an RGP material such as an enflufocon or hexafoconhaving a thickness of about 50 μm can have a relative rigidity suitablefor epithelial smoothing and so as to conform at least partially to theablated stroma. The rigid silicone having a modulus of about 20 MPa anda thickness of about 250 μm will provide a relative rigidity 3E-4 anddeflection under load similar to the RGP material having a thickness ofabout 50 μm and modulus of about 1900 MPa so as to provide a relativerigidity of about 2.4E-4. Commercially available RGP lens materials asshown in Table A1 can be combined in accordance with embodiments asdescribed herein so as to provide device 100. Based on the teachingsdescribed herein, a person of ordinary skill in the art can determinethe thickness of the device based on the modulus and the intendedrelative rigidity.

Work in relation to embodiments in accordance with clinical studies asdescribed herein has shown that the inner portion 110 of the device 100having the relative rigidity of about 3E-4 (3×10⁻⁴ Pa-m³) can beeffective so to improve vision and conform at least partially of the eyeso as to provide at least some comfort and improve fitting. Many eyeshave been measured with many devices and work in relation to embodimentsindicates that an inner portion 110 having a relative rigidity within arange from about 1E-4 to about 5E-4 (Pa-m³) can allow the device toconform to the ablation and smooth the epithelium as described herein.For example, inner portion 110 may a relative rigidity within a rangefrom about 2E-4 to about 4E-4, and the eye can be fit accordingly basedon the deflection of the device 100.

The relative rigidity can be related to the amount of deflection of thedevice 100 on the eye. Work in relation to embodiments indicates that arelative rigidity of inner portion 110 about 3E-4 can deflect about ±2Dwhen placed on the eye so as to conform to an ablation to within about±2D across the approximately 5 mm or 6 mm ablation diameter when aninner diameter of about 2 mm or 3 mm is smoothed. A device 100 having arelative rigidity of about 1.5 E-4 can deflect about ±4D when placed onthe eye so as to conform to an ablation to within about ±4D across anapproximately 5 mm or 6 mm diameter when an inner diameter of about 2 mmor 3 mm is smoothed.

The o-n, for example for coverings having a plurality of layers having aplurality of materials.

TABLE A3 Relative Rigidity of Layered Devices Material 2 (Soft)Composite Material 1 (Rigid) Flexural Composite Relative Total LayeredThickness Modulus Thickness Modulus Thickness Modulus Rigidity ThicknessMaterial (m) (Pa) (m) (Pa) (m) (Pa) (Pa-m³) 270 μm Exemplary 2.40E−042.00E+07 3.00E−05 2.00E+06 2.70E−04 1.80E+07 3.54E−04 thick SiliconeShield Soft and 1.35E−04 2.00E+07 1.25E−04 2.00E+06 2.70E−04 1.13E+071.99E−04 Hard are Equal 150 μm Exemplary 1.20E−04 2.00E+07 3.00E−052.00E+06 1.50E−04 1.64E+07 5.54E−05 thick Silicone Shield Soft and7.50E−05 2.00E+07 7.50E−05 2.00E+06 1.50E−04 1.10E+07 3.71E−05 Hard w/Equal thickness

When two or more materials are combined so as to provide two or morelayers, the relative rigidity of each layer can be combined so as todetermine a total composite rigidity. For example, the combined rigiditycan be determined for a device having first layer 110L1 of firstmaterial, a second layer 110L2 of second material M2 and third layer110L3 of third material 110L3, in which the first and third materialscan be the same material.

A weighted average system can be used to treat the two layers as onematerial. The relative amounts of each material and the moduli of thetwo materials can be combined to determine a composite modulus based onthe weight average of the thickness of each layer. For example, with 90μm of 20 MPa material layer and a 10 μm of 5 MPa material layer can becombined so as to determine the composite modulus as

20 MPa×0.9+5 MPa×0.1=18.5 MPa

The equations described herein accommodate many layers of differentmaterials and thicknesses.

Based on the composite modulus, one can multiply the composite modulusby the overall thickness cubed, in the present example 18.5 MPa×100³.Although these calculations can be based on approximations, a person ofordinary skill in the art can conduct simulations, for example finiteelement modeling simulations, so as to determine the amount of relativerigidity, pressures and deflection forces and pressures as describedherein.

The index of refraction of one or more layers of device 100 maycorrespond substantially to the index of refraction of the cornea.

One or more of the materials 110M1, 110M2 or 110M3 may comprise an indexof refraction within a range from about 1.38 to about 1.43 so as tomatch the index of refraction of the cornea to within about ±0.05. Forexample the materials 110M1 and 110M3 may comprise an opticallytransparent soft silicone elastomer having an index of refraction ofabout 1.41 and the material M2 may comprise an optically transparentrigid silicone elastomer having an index of refraction of about 1.43,for example available from NuSil. Alternatively, material 110M1 andmaterial 110M3 may comprise silicone silicone or hydrogel and material110M2 may silicone, for example.

While the device may comprise similar materials such as a more rigidsilicone combined with a softer silicone, the device may comprisedissimilar materials. For example, an RGP material can be combined witha silicone or hydrogel, such as the bicurve or tricurve embodiments asdescribed herein. The device can extend at least to the limbus forstability. The RGP material may comprise the second layer 110L2 of thesecond material 110M2, for example in accordance with Table A1, and thehydrogel may comprise the first layer 110L1 of the first material 110M1and the third layer 110L3 of the third material 110M3. The hydrogel mayhave an index of refraction from about 1.38 to about 1.42 so as to matchthe index of refraction of the cornea of about 1.377 to within about0.05 and may comprise one or more of HEMA, NVP, GMA, MMA, SiH, TRS,HEMA/NVP, MMA/NVP, HEMA/GMA, or SiH/TRS, commercially available fromVista Optics, UK, for example. The hydrogel comprising HEMA/NVP,MMA/NVP, or HEMA/GMA may have a water content within a range from about40% to about 70% so as to provide an index of refraction within a rangefrom about 1.38 to about 1.43. A water content of about 40% correspondsto an index of refraction of about 1.43 and a water content of about 70%corresponds to an index of refraction of about 1.38. A hydrogelcomprising SiH/TRS may comprise water content within a range from about20% to about 70% so as to provide an index of refraction within a rangefrom about 1.38 to about 1.43. With these SiH hydrogels a water contentof about 20% corresponds to an index of refraction of about 1.43 and awater content of about 70% corresponds to an index of refraction ofabout 1.38.

FIG. 2A shows a device 100 comprising a contact lens placed on the eyewith the eyelids separated, in accordance with certain embodiments. Adevice 100 is placed on the eye such that the tear liquid TL extendsunder at least a portion of the device between the device and the corneaso as to provide a chamber 100C. The device 100 can be fit on K orslightly flatter than the cornea so as to provide chamber 100C.Alternatively or in combination, the flange 120F and sclera couplingportion 120S of the outer portion 120 may comprise an angle steeper thanthe conjunctiva such the device is urged away from the cornea near innerportion 110 so as to provide chamber 100C. The device 100 comprises asag height 105S1 corresponding to the elevation distance from the centerof the device to the outer perimeter 120P of the sclera coupling portion130. The eyelids can be separated for the patient to see an object.

FIG. 2B shows a profile view of the device of FIG. 2A with the eyelidsclosing.

FIG. 2C shows a front view the device of FIG. 2A with the eyelidsclosing, in accordance with embodiments. The eyelids can close with adownward movement 22A of the upper eyelid and an upward movement 22B ofthe lower eyelid. The closing of the eyelids exerts pressure on thedevice 100 such that device 100 comprises second configuration 100C2.The second configuration 100C2 comprises the sag height 105 decreased tosecond sag height 105S2 such that the volume of chamber 100C decreasesand urges pumped tear fluid 100TL from under the device. The pumped tearliquid 100TL flows radially outward under the outer portion 120P andthrough fenestrations 100F such as fenestrations not covered by theeyelid. The pressure of the eyelid can urge the device 100 toward cornea100 so as to decrease the volume of chamber 100C. The volume of chamber100C can decrease substantially when the outer portion 120 comprisingflange 120F deflects with elastic deformation. Alternatively or incombination, the outer portion 120 corresponding to the cornea candeflect so as to decrease the volume of chamber 100C. In certainembodiments, the inner portion 110 comprising optical component 100A maydeflect with pressure of the eyelid so as to decrease the volume ofchamber 100.

FIG. 2D shows a side profile of the device of FIG. 2A with the eyelidsopening, in accordance with embodiments. When the eyelids retract withupward movement 22C of the upper eyelid and downward movement 22D of thelower eyelid, the device 100 can return to the first configuration 100C1having first sag height 105S1, such that the volume of the chamberincreases. The outer portion 120 comprising flange 120F and peripheralportion 120F of the sclera coupling portion 130 may contact theconjunctiva so as to form a contact seal with the conjunctiva. Thecontact seal with the conjunctiva encourages flow of the tear liquid TLthrough the fenestrations 100F and into the chamber 100C, such thatpumped tear liquid 100TL can be located between the cornea and thedevice 100.

The tear rivulet of the lower lid can move upward when the eyes close soas to provide tear liquid on the surface of the eye, and at least aportion of the rivulet can couple to the upper lid when the lids contacteach other. When the upper lid moves upward with movement 22C and thelower lid moves downward with movement 22D, the upper lid provide tearliquid TL near the upper fenestrations to pass through the upperfenestrations and the lower lid can provide tear liquid TL near thelower fenestrations to move through the lower fenestrations.

Repeated blinking of the eye may occur naturally, so as to pump tearliquid under the covering and rinse the cornea and conjunctiva under thedevice. This pumping and rinsing provided by the device can extend theamount of time the device can be worn by a patient such as a patienthaving a normal unablated eye, and may encourage epithelial regenerationin post-PRK eyes, for example.

FIG. 2E shows a device comprising a contact lens placed on the eye suchthat the device is supported with an inner portion of the cornea and theconjunctiva with the device separated from an outer portion of thecornea so as to define a chamber when the eyelids are separated, inaccordance with embodiments. The device 100 may contact the cornea at aninner portion of the cornea, for example at a central location. Theinner portion 110 can be sized to fit the cornea centrally as describedherein, for example with on K fitting. The outer portion of the device120 comprising flange 120F and sclera coupling portion 130 can be sizedto contact the conjunctiva when the inner portion 110 contacts thesclera centrally, such that chamber 100C is formed over the outerportion of the cornea with a gap extending between the outer portion ofthe cornea and the device. The outer portion 120 of the device extendingover the outer portion of the cornea may have a curvature less than thecornea, such that the outer portion 120 over the outer portion of thecornea can form chamber 100C when the inner portion 110 is supportedwith the cornea and the outer portion 120 comprising flange 120F iscoupled to the conjunctiva. The fenestrations 100F can be located on thedevice to correspond with a location of chamber 100C and the gap whenthe eyelids are open. The outer portion 120 comprises a resistance todeflection sufficient to form chamber 100C when the eyelids are open aninsufficient to resist deflection when the eyelids move over the outerportion such that the outer portion moves toward the cornea and decreasethe gap distance when the eyelids close.

The device 100 can be fit to the cornea to encourage formation of thechamber 100C and such that device 100 comprises an initial configuration100C1 with chamber 100C formed beneath. The cornea may comprise a limbussag height 105L corresponding to an elevational distance extending froma vertex of the cornea to the limbus. The limbus may be located a radialdistance 105RL from a measurement axis of the eye. The eye may comprisea conjunctiva sag height 105C at a radial distance 105RC from the axisof the eye. The device may comprise a limbus sag height 105LC at alocation corresponding to the radial distance RL to the limbus. Thedevice may comprise a conjunctiva sag height 105CC at a conjunctivacontacting location corresponding to the radial distance 105RC of theconjunctiva, for example along flange 120F. In certain embodiments, thesag height 105LC of the device at the location corresponding to thelimbus is no more than the limbus sag height 105L, and the sag height105CC of the device at the location corresponding to the conjunctiva isno more than the conjunctiva sag height 105C, such that pressure to thelimbus is decreased. When the device is placed on the eye, theconjunctiva coupling portion 130 comprising flange portion 120F candeflect such that the sag height of the conjunctiva contacting portionis decreased from 105CC the sag height of the conjunctiva to the sagheight of the conjunctiva 105C, such that the sag height of the devicecomprises a sag deflected sag height 105S2.

FIG. 2F shows a side sectional view of the device of FIG. 2E with theeyelids closing such that device 100 comprises a configuration 100C2with chamber 100C having a decreased volume. When the eyelids close, theupper and lower lids exert pressure on the device such that the deviceis urged toward the outer portion of cornea and the conjunctiva. Theouter portion of the device over the outer portion of the cornea may nothave sufficient resistance to deflection such that the outer portion ofthe device is deflected downward toward the outer portion of the cornea.The gap distance extending between the outer portion of the device overthe outer portion of the cornea is decreased, such that the volume ofchamber 100C decreases and pumped tear liquid 100TL flow from chamber100C through fenestrations 100F and under the conjunctiva contactingportion 130 comprising flange portion 120F. The upper eyelid can extendacross the pupil so as to cover inferior and superior fenestrations100F. The upper eyelid may contact the lower eyelid so as to draw thetear liquid of the rivulet superiorly when the eye opens, such that tearliquid of the rivulet can be drawn into the chamber through the inferiorand superior fenestrations.

The deflection of the outer portion of the device over the outer portionof the cornea can be provided with a device having a relative rigiditywithin a range from about 1.0 E-6 Pa-m³ to about 6 E-4 Pa-m³, forexample from about 2.5 E-6 Pa-m³ to about 5 E-4 Pa-m³. Table A2 showsvalues suitable of relative rigidity and corresponding ranges of outerportion 120 corresponding to the outer portion of the cornea that can bedetermined based on the teachings described herein so as to determinethe relative rigidity of the outer portion of the device to provideresistance to deflection and form the chamber with the gap when theeyelid is away from the portion of the device and so as to deflecttoward the cornea and decrease the gap and corresponding chamber volumewhen the eyelid covers the portion of the device.

The deflection of the sclera contacting portion 130 to couple to theconjunctiva can be provided with the sclera contacting portion 130comprising a relative rigidity of no more than about 2 E-4 Pa-m³, forexample no more than about 1 E-4 Pa-m³, and in certain embodiments nomore than about 2 E-5 Pa-m³. Table A2 shows values suitable of relativerigidity and corresponding ranges of sclera coupling portion 130 thatcan be determined based on the teachings described herein so as todetermine the relative rigidity of the sclera coupling portion of thedevice to provide resistance to deflection and form the chamber with thegap when the eyelid is away from the portion of the device and so as todeflect toward the cornea and decrease the gap and corresponding chambervolume when the eyelid covers the outer portion of the device over theouter portion of the cornea.

The deflection of the flange portion 120F to couple to the conjunctivacan be provided with the flange portion 130 comprising a relativerigidity of no more than about 1 E-4 Pa-m³, for example no more thanabout 2 E-5 Pa-m³, and in certain embodiments no more than about 2.5 E-6Pa-m³. Table A2 shows values suitable of relative rigidity andcorresponding ranges of outer flange portion 120F that can be determinedbased on the teachings described herein so as to determine the relativerigidity of the flange portion 120F of the device to provide resistanceto deflection and form the chamber with the gap when the eyelid is awayfrom the portion of the device and so as to deflect toward the corneaand decrease the gap and corresponding chamber volume when the eyelidcovers the outer portion of the device over the outer portion of thecornea.

FIG. 2F1 shows a profile view of the device of FIG. 2F with rotation ofthe eye when the lids close such that sliding of the device along theepithelium is inhibited when tear liquid is pumped, in accordance withcertain embodiments. The axis of the eye can rotate superiorly such thatthe device slides along the upper lid and the lower lid. The axis of theeye may comprise one or more known axis of the eye and can be determinedin many ways by a person of ordinary skill in the art.

FIG. 2G shows a profile view of the device of FIG. 2E with the eyelidsopening, in accordance with embodiments. The opening of the eyelidsdecreases pressure and allows the outer portion of the device above theouter portion of the cornea to move away from the cornea. The tearliquid TL may pass through fenestrations 100F and into the chamber 100C.The outer portion of the device comprising portion 130 and flange 120Fcan contact the conjunctiva to inhibit tear flow and may seal thedevice.

FIG. 2H shows a profile view of the device of FIG. 2E with the eyelidslocated at an intermediate location such that the chamber comprises anintermediate configuration 100C12 volume, in accordance withembodiments. The optical component 100A comprising inner portion 110 maycomprise sufficient rigidity and resistance to deflection so as toprovide vision for the patient when the device comprises intermediateportion 100C12 having outer portion 120 deflected so as to decreasevolume of chamber 100C. For example, the patient can close the eyelidsto the pupil margin to deflect the outer portion and the opticalcomponent 100B and inner portion 110 can remain substantiallyundeflected such that the patient can have vision of 20/20 or better(metric 6/6 or better) with a portion of one or more eye lids contactingthe inner portion 110. Opening of the eyelids can increase the chambervolume and pump tear liquid and closing of the eyelids can decreasechamber volume and pump tear liquid.

FIG. 2I shows a side view sectional view of the device of FIG. 1C4placed on the eye with silicone or hydrogel contacting the eye. Thedevice 100 comprises the layer of silicone or hydrogel material 120MHGextending along the posterior surface of the device so as to contact theeye with at least a portion of the silicone or hydrogel layer. Thedevice 100 can be dimensioned to form chamber 100C defined at least inpart with the layer of silicone or hydrogel material. Fenestrations mayextend through the silicone or hydrogel layer so as to provide pumpingas described herein. Alternatively or in combination, the posterior endof the fenestrations can be covered with the silicone or hydrogelmaterial to couple the cornea to the fenestrations with the layer ofsilicone or hydrogel material. Fenestrations covered with the layer ofsilicone or hydrogel material 120MHG can be located along thedeflectable portion of the device so as to encourage movement of waterand therapeutic agents along the silicone or hydrogel material, forexample when the eye blinks. The silicone or hydrogel layer may comprisea medium to pass liquid and therapeutic agent from the fenestrations toa desired location of the cornea, for example with wicking of the liquidand therapeutic agent to a central location of the cornea. The devicecomprising the silicone or hydrogel layer extending along the lowersurface as described herein can be fit to an unablated eye to providerefractive correction or fit to an ablated eye as described herein.

Clinical testing in accordance with embodiments has shown that thecurved portions of the device can be fit with on K values in accordancewith corneal curvatures and sag heights and limbus sag heights andconjunctiva sag heights of a patient population.

Appendix I shown herein below provides dimensions and fit parameters fordevice 100 in accordance with embodiments and teachings as describedherein. The devices may comprise one or more of the materials in theSeries A Tables shown herein, for example. The dimensions and fitparameters of the devices can provide pumping of the tear liquid whenplaced on the cornea in accordance with embodiments described herein.The tables of Appendix I identify the devices for use with steep Kcorneas, medium K corneas and flat K corneas, for example. The K valueslisted can be based on population norms, such that the devices providepumping as described herein when placed on the eye. The devices can beused with non-ablated eyes or ablated eyes, and the device can beidentified at least in part based on the first inner curvature R1.

Table B1 shows device 100 having a diameter of approximately 14 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about 7mm to 9 mm across. The portion corresponding to radius R1B3 hasdimensions of about 9-11 mm across. The portion corresponding to R1C1can extend from about 11 mm to 13.5 mm across, and may comprisecurvature having one or more values between portion R1B3 and portionR1C2, for example a radius of curvature between about 8 mm and about 12mm such as about 10 mm. The portion corresponding to R1C2 can extendfrom about 13.5 mm to 14 mm across. The sag height of the portion R1C2can be from about 3.1 mm to about 3.4 mm, for example. The portioncorresponding to R1C1 can be fit to the cornea in many ways as describedherein, for example with the tangent of portion R1C1 aligned with R1B3on the inner boundary and R1C2 along an outer boundary so as to inhibitridge formation as described herein.

Table B2 shows device 100 having a diameter of approximately 14 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about7-9 mm across. The portion corresponding to radius R1B3 has dimensionsof about 9-11 mm across, and these values range from about 35.75 toabout 40, such that each value is somewhat flatter at the peripheralportion than corresponding values of Table B1. For example, Table B1lists the values for R1B3 as having a range from about 36.75 to about 41D. The portion corresponding to R1C1 can extend from about 11 mm to 13.5mm across. The portion corresponding to R1C2 can extend from about 13.5mm to 14 mm across. The sag height of the portion R1C2 can be from about3.1 mm to about 3.4 mm, for example. The portion corresponding to R1C1can be fit to the cornea in many ways as described herein, for examplewith the tangent of portion R1C1 aligned with R1B3 on the inner boundaryand R1C2 along an outer boundary so as to inhibit ridge formation asdescribed herein.

Table B3 shows device 100 having a diameter of approximately 16 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about7-9 mm across. The portion corresponding to radius R1B3 has dimensionsof about 9-10.5 mm across, and these values range from about 36.75 toabout 41. The portion corresponding to R1C can extend from about 13 toabout 16 mm across. The sag height of the portion R1C2 can be less thanabout 3.6 mm, for example, such that portion R1C2 can be deflected whenplaced on the eye. The portion corresponding to R1C1 can be fit to thecornea in many ways as described herein.

Table B4 shows device 100 having curvatures for use with non-ablatedeyes so as to pump tear liquid as described herein, for example with anextended wear contact lens. Device 100 has a diameter of approximately14 mm across and can be fit on K or flatter, for example as describedherein. The table lists R1 corresponding to the center ablated portionof the cornea. The inner portion 110 comprising optical component 100Aand inner coupling component 100B1 has dimension R1 extends about 5 mmacross. The curvatures of the inner portion corresponding to R1 havecurvature values corresponding to optical powers from about 39 D toabout 48D, which can be based on population data for unablated eyes andcombined with the curvatures for portions R1B1 to R1B3 and R1C1 andR1C2, for example. The portion corresponding to radius R1B1 hasdimensions of about 5-7 mm across, and the curvature can be expressedwith keratometry values (K-values) corresponding to the optical power ofthe eye in Diopters (D). The portion corresponding to radius R1B2 hasdimensions of about 7-9 mm across. The portion corresponding to radiusR1B3 has dimensions of about 9 mm to 11 mm across. The portioncorresponding to R1C1 can extend from about 11 mm to about 13.5 mmacross. The portion corresponding to R1C2 can extend from about 13.5 mmto 14 mm across. The sag height of the portion R1C2 can be from about3.1 mm to about 3.4 mm, for example. The portion corresponding to R1C1can be fit to the cornea in many ways as described herein, for examplewith the tangent of portion R1C1 aligned with R1B3 on the inner boundaryand R1C2 along an outer boundary so as to inhibit ridge formation asdescribed herein.

Although Tables B1-B4 list specific curvature values by way of example,a person of ordinary skill in the art can determine many curvaturevalues based on the teachings and embodiments described herein and oneor more of the curvatures can be combined with an aspheric surface, forexample an aspheric surface having a conic constant.

FIG. 3A shows a device 100 positioned on cornea 10 an eye 2 having anepithelial defect 11. The device may comprise a curved body, for examplea curved contact lens body shaped to fit the cornea.

The device 100 can be sized to cover the ablated profile and epithelialdefect. The inner portion 110 comprises a dimension across 102 that canbe sized to extend across a majority of the ablation, and the outerportion 120 comprises a dimension across 104 sized to extend across atleast the epithelial defect and contact the epithelium on opposite sidesof the defect.

The dimension 102 extending across a majority of the ablation may extendabout 6 to 8 mm, for example, and may be sized larger than the ablation.The dimension 104 may comprise about 12 mm to 14 mm across, for exampleso as to extend to the limbus and can be sized to the limbus of thepatient for example. Work in relation to embodiments suggests that thedevice sized to extend to the limbus and circumferentially around thelimbus can be centered on the cornea. The device may extend such thatthe outer rim of the device contacts the conjunctiva disposed above thesclera peripheral to the limbus, for example, and that suchconfigurations may center the lens on the cornea, for example.

The thickness of the device can be sized and shaped in many ways. Theinner portion 110 of the device comprises a thickness 106 and the outerportion 120 of the device comprises a thickness 108. The thickness 106of the inner portion may comprise a substantially uniform thickness suchthat the inner portion comprises an optical power of no more than about±1D prior to placement on the eye, for example when held in front of theeye and separated from the cornea by a distance. Alternatively, thethickness of the inner portion may vary so as comprise optical power,for example optical power to correct vision of the patient.

A smooth layer 12S of regenerated epithelium 12R may substantially coveran ablated profile. The environment 100E is configured to guideepithelial regeneration and smooth the regenerated epithelium. Theregenerating epithelium comprises a thickness profile 12RP.

The epithelium grows centripetally from circumscribing boundary 12Etoward the center of ablated profile 20 to cover the exposed stroma, asindicated by arrows 30.

The device 100 may comprise an inner portion 110 and an outer portion120. The outer portion 110 can be configured to form a seal 100S withthe cornea near the edge of the ablation and the epithelial defect, forexample with a soft conformable material such as silicone elastomer orsilicone hydrogel. The inner portion 120 is positioned over the pupiland configured for the patient to see, and may comprise a rigiditygreater than the outer portion, so as to smooth irregularities of theepithelium when the cornea heals. Alternatively, the inner portion maycomprise rigidity equal to or less than the rigidity of the outerportion as well. For example, the inner portion may comprise siliconeand the outer portion may comprise silicone, and the inner portion maycomprise one or more of a more rigid silicone or a greater thicknesssuch that the inner portion can be more rigid than the outer portion soas to smooth the epithelium. Although the inner portion can be morerigid than the outer portion, the inner portion can be sufficientlysoft, flexible and conformable so as to conform at least partially tothe ablated profile 20 in the stroma, such that the patient receives thebenefit of the vision correction with the ablation profile 20 when thepatient looks through the inner portion and the inner portion smoothesthe epithelium. Work in relation to embodiments of the present inventionsuggests that the regenerating epithelium is softer than the underlyingstroma of ablation profile 20, such that the inner portion can beconfigured to conform to the shape of the ablation profile 20 when theinner portion smoothes the epithelium disposed under the inner portion,for example with deflection pressure as described herein.

FIG. 3B shows device 100 in a first configuration prior to placement onthe cornea of an eye having an epithelial defect, such as an eye havinga PRK ablation. The device 100 comprises fenestrations 100F. Thefenestrations 100F can be located on the device such that thefenestrations are located away from the epithelial defect to pump tearliquid under the device as described herein. The device 100 may compriseinner portion 110 having a base radius R1 of curvature, and the baseradius of curvature may be slightly longer than the ablated cornea suchthat the device can be flatter than the cornea prior to placement on thecornea. The outer portion 120 comprising sclera coupling portion 130 maycomprise a portion steeper than the cornea to reduce pressure to thelimbus. For example flange portion 120F can be steeper than thecorresponding portions of conjunctiva and sclera so as to decreasepressure of the device on the limbus.

The base radius R1 can be sized to the cornea in many ways. For example,the base radius R1 may have a radius corresponding to the post ablatedeye.

The device 100 may comprise a modulus within a range from about 4 MPa toabout 35 MPa, such that central portion can conform at least partiallyto the ablated stroma and so that the device can smooth cornealirregularities and stromal irregularities of the ablated cornea. Thedevice may comprise an elastomeric stretchable material such that thedevice can stretch to fit the cornea, for example. The device having themodulus within a range from about 4 MPa to about 35 MPa can be formed inmany ways as described herein. For example, the device may comprise asingle piece of material having a substantially uniform thicknessextending across the ablated cornea and at least a portion of theunablated cornea, and the single piece of material may comprise anelastic material such as a silicone elastomer or a hydrogel.Alternatively, the device may comprise a single piece of material havinga non-uniform thickness extending across the ablated cornea and at leasta portion of the unablated cornea. The device can be shaped in many waysand may comprise a single piece of one material, or may comprise asingle piece composed to two similar materials, or may comprise aplurality of materials joined together.

The device 100 may comprise one or more outer portions extending outsidethe inner portion as described herein.

FIG. 3C shows the device of FIG. 3B placed on the eye having a secondconfiguration 100C2 conforming to ablated stromal tissue and smoothingthe epithelium over the ablated stroma, such that the device can pumptear liquid as described herein. The cornea comprises an ablated surface20 to correct vision that may have a corresponding radius of curvature,for example radius R2. The ablated profile 20 may comprise additional,alternative, or combinational shapes with those corresponding to radiusR2, such as aberrations ablated into the cornea to correct aberrationsof the eye and astigmatism ablated into the cornea, and the innerportion 110 of device 100 can conform to these ablated profiles of thecornea such that the patient can receive the benefit of the ablativevision correction when the device is positioned on the cornea. Forexample, the cornea ablation profile 20 may correspond to radius ofcurvature R2, and the inner portion 110 can flatten from configuration100C1 corresponding to radius of curvature R1 prior to placement to asecond configuration 100C2 corresponding substantially to the ablatedprofile 20, such the patient can see with the benefit of ablationprofile 20. For example, the second configuration 100C2 can comprise aconforming radius of curvature R12 that corresponds substantially toradius of curvature R2. The profile corresponding to the firstconfiguration 100C1 of the device 100 is shown positioned over cornea 10to illustrate the change in profile of the device from configuration100C1 prior to placement to conforming configuration 100C2 of the device100 when positioned on the cornea.

The conformable device 100 comprises sufficient rigidity so as to smooththe epithelium when device 100 is positioned on the cornea over theablation profile 20. The epithelium comprises a peripheral thickness 12Tthat may correspond substantially to a thickness of the epithelium priorto debridement of the epithelium to ablate the cornea. The epitheliumalso comprises regenerating epithelium 12R disposed over the ablationprofile 20. The device 100 can smooth the epithelium 12R when conformingto the cornea in the second configuration 12C2. For example,irregularities 121 of the regenerating epithelium 12R disposed over theablation can be smoothed when the epithelium regenerates along the innerportion of device 100, such that the irregularities 121 of theregenerating epithelium 12R are thinner than the thickness 12T of theperipheral epithelium.

Work in relation to the embodiments as described herein indicates thatan at least partially conformable device having a modulus within a rangefrom about 4 MPa to about 35 MPa can conform at least partially to theablated stroma and smooth irregularities of the epithelium and stroma soas to improve vision as described herein. The device having the moduluswithin the range from about 4 MPa to about 35 MPa can be formed in manyways as described herein.

FIGS. 4A to 4H show a method 400 of manufacturing a device 100 andapparatus for manufacturing the device as described herein.

FIG. 4A shows a mold 600A to form an optical component 100A of a device100 comprising material 110M as described herein. The optical component100A may comprise an optically transparent material such as a silicone,for example. The optical component may comprise a modulus and thicknessand corresponding rigidity as described herein, so as to provide visionand smoothing of the cornea. The mold 600A may comprise an opticalcorrection on one surface and a base curvature on the opposite surface,for example. With a step 410, the optical component 100A can be formedin mold 600A.

FIG. 4B shows a mold 600B to form a device comprising the opticalcomponent of FIG. 4A and the coupling component 100B. The opticalcomponent 100A can be placed in the mold and the flowable material 120Mof the coupling component injected into the mold so as to form thedevice. The solid inner component comprising a rigid material placedtherein prior to injection of a flowable material. The mold 600B maycomprise inner material 110M positioned within the mold as a solid pieceof material and outer material 120M comprising a flowable materialinjected into mold 600B and cured around the preformed piece comprisinginner material 120M. The flowable material can be injected around theinner material 100M in many ways. For example, the inner material 110Mmay comprise a second layer 110L2 of rigid material 110M2 of the innerportion 110 as described herein, and the flowable material can beinjected around the upper and lower surfaces of second material 110M2 soas to form a first layer 110L1 of first material 110M1 and a third layer110L3 of the third material 110M3 with the flowable material such thatthe first material 110M1, the third material 110M3 and the outermaterial 120M each comprise substantially the same soft material whencured. With a step 420, the device comprising the optical component 100Aand the coupling component 100B can be formed.

FIG. 4C shows a mold 600C to form a device comprising the opticalcomponent of FIG. 4A and a layer of a soft material of the device, suchthat the optical component can be located between two layers of thecoupling component. The optical component 100M can be removed from themold as shown in FIG. 4A and placed in the mold 600C. The flowablematerial M3 corresponding to layer 110L3 can be injected into the moldand cured. The partially formed inner component comprising layer 110L2and layer 110L3 can be removed from mold 600C. With a step 430, theportion of the device comprising the two layers can be formed.

FIG. 4D shows a mold 600D to form a device and having a solid innercomponent comprising the rigid material placed for injection of aflowable material, in accordance with embodiments of the presentinvention. The mold 600 may comprise inner material 110M positionedwithin the mold as a solid piece of material and outer material 120Mcomprising a flowable material injected into mold 600 and cured aroundthe preformed piece comprising inner material 600. The mold may comprisean upper portion and a lower portion. In certain embodiments, the device100 can be formed in a mold with rigid second material 110M2 placed inthe mold and encapsulated within a single piece of material comprisingfirst material 110M1, third material 110M3 and outer material 120M, suchthat first material 110M1, third material 110M3 and outer material 120Mcomprise the same material, for example silicone. The rigid secondmaterial 110M2 may comprise silicone bonded to each of first material110M1, third material 110M3 and the outer material 120M, for examplewith curing such that first material 110M1, third material 110M3 andouter material 120M comprise the same soft silicone material bonded tothe second material 110M2 comprising rigid silicone. With a step 440,the device comprising the solid inner component between first material110M1 and third material 110M3 can be formed.

FIG. 4E shows formation of fenestrations in the device with energy. Witha step 450 the device as described in FIG. 4B or FIG. 4D can be treatedwith energy 650, for example mechanical energy or electromagnetic energysuch as light energy to form the fenestration extending through thedevice. For example, the fenestration can be removed from the mold andmechanically punched or ablated with laser light energy to form thefenestration.

FIG. 4F shows spin coating of a silicone or hydrogel material on aposterior surface of the device. An amount of a curable silicone orhydrogel forming material 660 as described herein can be deposited onthe posterior surface of the device and spun with rotation 662 at ratesuch that the coating moves away from a center of the device toward andouter boundary of the silicone or hydrogel material. The outer boundaryof the silicone or hydrogel material can be determined based on theamount of curable material 660 and spin rate, and the curable siliconeor hydrogel material can be formulated to provide the desired thicknessas described herein, for example a substantially uniform thicknesswithin a range from about 1 μm to about 100 μm when fully hydrated. Witha step 460, the curable silicone or hydrogel forming material 660 can becured so as to provide the layer of silicone or hydrogel material on thelower surface of the device 100.

FIG. 4G shows chemical vapor deposition on the device having thesilicone or hydrogel material formed thereon. The device 100 can beplaced in a chemical vapor deposition chamber 670, and treated with oneor more forms of chemical vapor deposition as described herein. With astep 460, the device 100 can be coated with the CVD to provide thewettable material on the surface of the device.

FIG. 4H shows the device comprising 100 the silicone or hydrogelmaterial 120HG packaged in a container 680. The device can besterilized, and can be packaged wet or dry, or combinations thereof incontainer 680. For example, the device can be placed with a fluidcomprising saline in the container. Alternatively, the device 100 can bedry packaged in container 680, for example. With a step 480, the device100 can be placed on container 680 and the container sealed.

It should be appreciated that the specific steps illustrated in method400 provide a particular method of manufacturing a device, according toan embodiment of the present invention. Other sequences of steps mayalso be performed according to alternative embodiments. For example,alternative embodiments of the present invention may perform the stepsoutlined above in a different order. Moreover, the individual stepsillustrated may include multiple sub-steps that may be performed invarious sequences as appropriate to the individual step. Furthermore,additional steps may be added or removed depending on the particularapplications. One of ordinary skill in the art would recognize manyvariations, modifications, and alternatives.

A method 500 of manufacturing device 100 comprising a contact lens topump tear liquid may comprise one or more of the following steps:

505—Provide first mold for optical component

510—Inject first flowable material into first mold

515—Cure first flowable material to form first optical component

520—Remove first optical component from first mold

525—Place first optical component in second mold

530—Inject second curable material into second mold

535—Cure second flowable material to form second component

540—Remove second component from second mold

545—Place second component in third mold

550—Inject third flowable material into third mold

555—Cure third flowable to form device

560—Remove device

565—Drill fenestrations

570—Coat with wettable material

The rigidity and hardness of the molded device can be determined by oneor more of the material hardness, the modulus or the thickness. Themolded device may comprise a device with an inner center more rigid thanthe outer periphery, for example, and the center can be thicker thanedge. For example, the device may comprise a single piece device with aninner portion thicker than the outer portion such that the inner portionis more rigid than the outer portion. Alternatively or in combination,an optically clear inner portion can be molded; the inner portion placedin the mold, and the device molded to form the outer portion around theinner portion. For example, the molded inner portion comprising layer110L2 of material 110M2 as described herein, and one or more of layers110L1 or 110L3 molded around layer 110L2.

It should be appreciated that the specific steps illustrated in Method500 provide a particular method of manufacturing a device, according toan embodiment of the present invention. Other sequences of steps mayalso be performed according to alternative embodiments. For example,alternative embodiments of the present invention may perform the stepsoutlined above in a different order. Moreover, the individual stepsillustrated may include multiple sub-steps that may be performed invarious sequences as appropriate to the individual step. Furthermore,additional steps may be added or removed depending on the particularapplications. One of ordinary skill in the art would recognize manyvariations, modifications, and alternatives.

Clinical studies have been undertaken and are contemplated to show thepumping of the tear under the lens with blinking of the eye inaccordance with the embodiments described herein. A person of ordinaryskill in the art can determine empirically the properties of device 100as described herein so as to provide pumping of the tear fluid under thedevice to provide one or more of an extended wear contact lens or adevice for placement on the cornea following PRK to improve vision andpromote reepithelialization.

As used herein, like reference characters indicate like structures thatcan be combined in accordance with the teachings and embodimentsdescribed herein.

In certain embodiments, methods for selecting ophthalmic lenses areprovided. The methods may be used to correct a refractive error of aneye of a patient, the eye having a cornea with a refractive shape. Incertain embodiments, methods for selecting ophthalmic lenses comprisedetermining a desired spherical power so as to mitigate any sphericalcomponent of the refractive error of the eye of the patient; andidentifying, from among a plurality of alternative ophthalmic lenseshaving differing spherical powers, the ophthalmic lens corresponding tothe desired spherical power. The identified ophthalmic lens may then beselected and applied to the eye of the patient to correct the sphericalrefractive error. The identified ophthalmic lens has an anterior surfacecorresponding to the desired optical power, and the anterior surfaceextends along an inner portion of the ophthalmic lens.

The ophthalmic lenses have an inner portion for correcting sphericalrefractive error and a peripheral portion for contacting an opticaltissue. The inner portion of the ophthalmic lens is deformable and theperipheral portion of the ophthalmic lens is deformable. The innerportion of the ophthalmic lens has a modulus and a rigidity that ishigher than the modulus and the rigidity of the peripheral portion. Theperipheral portion of the ophthalmic lens has a shape suitable forengaging the eye outside the optical region so as to support the innerportion in alignment with an optical region of the eye. In certainembodiments, the peripheral portion is configured to engage a tissue ofthe eye such as the epithelium and to prevent or minimize motion of theophthalmic device with respect to the optical region of the eye. Incertain embodiments, the inner portion, the peripheral portion, or boththe inner and peripheral portions may deform or deflect upon blinking ofthe eye.

In certain embodiments, the refractive shape of the epithelium extendsacross the optical region of the eye such that the refractive errorcomprises astigmatism and/or a high-order optical aberration. In suchembodiments, the posterior surface extending across the optical regionadjacent the eye may or may not comprise a refractive shape so as tomitigate the astigmatism and/or high-order aberration. Selection of adesired ophthalmic lens is performed so that the peripheral portion ofthe ophthalmic lens has a suitable shape to maintain a lenticular volumebetween the posterior surface of the ophthalmic device and the surfaceof the eye such as the epithelium. Before, during, and/or followingpositioning of the ophthalmic device on the eye, the lenticular volumefills with tear fluid such that the anterior shape of the ophthalmiclens corrects the refractive error. Accordingly, in certain methods,selecting an ophthalmic lens is performed so that the peripheral portionhas a suitable shape such that tear fluid will fill a lenticular volumebetween the posterior surface and the refractive shape of the eye so asto mitigate the astigmatism and/or high-order aberration. Where tearfluid is disposed between the contact lens and the eye, and where thelens has a refractive index sufficiently close to that of the tearfluid, the refraction of the eye may be largely independent of the shapethe posterior surface and/or lenticular volume, at least when theposterior surface initially contacts the lens and/or the contact lensremains disposed on the eye. In certain methods, identifying anophthalmic lens is independent of as least one member of the group apower of the astigmatism; and orientation of the astigmatism about anoptical axis of the eye, and/or as strength of the high-order aberrationand/or a type of high-order aberration. As a consequence of thelenticular volume as defined by posterior surface of the eye and therefractive shape being filled with tear fluid, it is not necessary toorient an axis or position of the ophthalmic device with the eye.

Ophthalmic lens provided by the present disclosure may also be used fortreating presbyopia. Methods for treating presbyopia comprise, forexample, positioning an ophthalmic lens on an eye so that an innerportion of the ophthalmic lens is disposed over the optical region ofthe cornea of the eye, and supporting the inner portion of theophthalmic lens by engagement between a peripheral portion of theophthalmic lens and a tissue of the eye outside the optical region. Theinner portion of the ophthalmic lens and the peripheral portion of theophthalmic lens can be deformable such that the inner portion has amodulus and rigidity that is greater than the modulus and rigidity ofthe peripheral portion. To correct for presbyopia, the inner portioncomprises a presbyopia-mitigating refractive shape. In certainembodiments, a presbyopia-mitigating shape is selected from an addregion, a multifocal shape, an aspherical shape, and a combination ofany of the foregoing. In certain embodiments, the peripheral portioncomprises one or more radius of curvature configured to engage a tissueof the eye such as the epithelium so as to prevent or minimize motion ofthe inner portion with respect to the optical region of the cornea. Theanterior portion of ophthalmic lens and the posterior surface of the eyedefine a lenticular volume that is configured to fill with tear fluid.To facilitate filling and/or flow of the tear fluid a plurality offenestrations extending through the thickness of the peripheral regionmay be disposed in the peripheral region. The fenestrations are disposedso as to facilitate, in conjunction with motion of the ophthalmic lens,transfer of tear fluid through the lenticular volume. Such methods oftreating presbyopia using an ophthalmic lens provided by the presentdisclosure may not require precise alignment of the ophthalmic lens withrespect to the eye.

Similarly, methods for correcting a refractive error of an eye, such asastigmatism and/or spherical aberration, where the eye has a cornea witha refractive shape extending a cross an optical region of the eye arealso provided. Methods for correcting a refractive error comprisepositioning an ophthalmic lens on the eye so that an inner portion ofthe ophthalmic lens is disposed over the optical region of the cornea,wherein a posterior surface of the positioned ophthalmic lens extendsadjacent the eye and has shape diverging from the refractive shape ofthe epithelium so that a lenticular volume is disposed between theposterior surface and the epithelium. A peripheral portion of theophthalmic lens may comprise a plurality of fenestrations extendingthrough the thickness of the peripheral portion and allowing passage oftear fluid between the lenticular volume and the posterior (outer)surface of the ophthalmic lens. In such embodiments, the inner portionof the positioned ophthalmic lens is supported by engagement of aperipheral portion of the ophthalmic lens and a tissue of the eye suchas the epithelium outside the optical region. The peripheral portion isconfigured to support the inner portion of the ophthalmic lens, toprevent or minimize motion of the inner portion with respect to theoptical region of the eye, and to facilitate filling of the lenticularvolume with tear fluid.

Fenestrations may be disposed outside the optical region of theophthalmic lens and inward of a region of engagement between theperipheral portion of the ophthalmic lens and a tissue of the eye. Theinner portion and the peripheral portion of the ophthalmic lens aredeformable, for example, deformable upon motion of an eyelid and/or overlocally protruding epithelial regions so as to inhibit pain, such thatthe inner portion has a modulus and rigidity that is higher than themodulus and rigidity of the peripheral portion. In certain embodiments,the deformability of the inner portion and the outer portion of theophthalmic lens are configured so that blinking of the eye induces flowof tear fluid through the fenestrations into and out of the lenticularvolume, and that when the eye is not blinking the inner portion retainsa shape that corrects the refractive error of the eye.

In certain embodiments, the peripheral portion comprises one or moreradius of curvature configured to engage a surface of the eye andthereby resist motion of the inner portion with respect to the opticalregion of the eye. For example, in certain embodiments, a peripheralportion comprises a plurality of radii of curvature wherein the radii ofcurvature become smaller from the center of the ophthalmic lens towardthe periphery. In certain embodiments, the engagement between theperipheral portion and the tissue surface of the eye along theengagement region inhibits lateral movement of the inner portionrelative to the cornea during blinking.

In certain embodiments, methods of correcting refractive error providedby the present disclosure can, for example, mitigate the refractiveerror, when viewing with the eye through the anterior surface,substantially independent of a shape of the lenticular volume throughouta range of astigmatic errors of at least about 0.5 D, at least about 1.0D, and in certain embodiments, at least bout 1.5 D, and is independentof a rotational orientation of the ophthalmic lens about a viewing axisof the eye.

Methods provided by the present disclosure further comprise methods ofremodeling the shape of the epithelium of an eye. In certainembodiments, methods for optically remodeling the relative shape of theepithelium comprise positioning an ophthalmic lens on the eye so that aninner portion of the ophthalmic lens is disposed over the optical regionof the cornea, wherein a posterior surface of the positioned ophthalmiclens extends adjacent the eye and has a shape diverging from therefractive shape of the epithelium so that a lenticular volume isdisposed therebetween; and supporting the inner portion of theophthalmic lens by engagement between a peripheral portion of theophthalmic lens and the eye outside the optical region so that fluidfills the lenticular volume and viewing with the eye through an anteriorsurface of the ophthalmic lens mitigates the refractive error. Inmethods of remodeling the shape of the epithelium to correct refractiveerror of the eye, the ophthalmic lens may (though not always) does notcomprise fenestrations. The posterior surface of the ophthalmic lensdefines a refractive shape for correcting spherical power and whenpositioned on the eye defines a lenticular volume with the surface ofthe eye. Over time, the epithelium and/or underlying tissue of the eyemay fill or otherwise occupy some, most, or all of the lenticular volumedisposed over the optical region. As with certain other embodiments, anophthalmic lens for use in remodeling the shape of the epitheliumcomprises a deformable inner portion and a deformable peripheral portionsuch that the inner portion has a higher modulus and rigidity than thatof the peripheral portion and the peripheral portion is configured toengage a tissue surface of the eye and to inhibit lateral movement ofthe inner portion with respect to the optical region of the cornea.

In certain embodiments, methods of remodeling the refractive shape ofthe epithelium mitigate the refractive error when viewing with the eyethrough the anterior surface, substantially independent of a shape ofthe lenticular volume throughout a range of astigmatic errors of atleast about 0.5 D, at least about 1.0 D, and in certain embodiments, atleast bout 1.5 D, and is independent of a rotational orientation of theophthalmic lens about a viewing axis of the eye.

Furthermore, when the ophthalmic lens is removed from the eye theoptical remodeling of the epithelium mitigates the refractive error ofthe eye by at least about 1½ D at least about 8 hours, at least about 24hours, and in certain embodiments, at least about 48 hours, afterremoval of the ophthalmic lens from the eye.

Certain embodiments provided by the present disclosure comprise sets ofalternatively selectable ophthalmic lenses for correcting refractiveerrors of eyes of a population of patients. Such sets of ophthalmiclenses may be used in the methods disclosed herein. The pluralityalternative ophthalmic lenses have differing spherical powersrepresenting different refractive corrections. Each of the plurality ofalternative ophthalmic lenses comprises an anterior surfacecorresponding to an associated desired spherical power, the anteriorsurface extending along an inner portion of the ophthalmic lens, whereinthe inner portion of the ophthalmic lens is deformable; and a peripheralportion of the ophthalmic lens extending radially outward from the innerportion, the peripheral portion having a rigidity lower than that of theinner portion and configured for engaging tissue outside the opticalregion so as to support the inner portion in alignment with an opticalregion.

In certain embodiments, ophthalmic lenses suitable for use in methodsprovided by the present disclosure comprise an inner portion configuredto be disposed over the optical region of the cornea of an eye, and aperipheral portion configured to support the inner portion of theophthalmic lens by engagement between the peripheral portion of a tissueof an eye such as an epithelium disposed outside the optical region. Theinner portion and the peripheral portion are deformable such that themodulus and rigidity of the inner portion is higher than that of theperipheral portion. In certain embodiments, the peripheral portioncomprises one or more radii of curvature whereby the peripheral portionengages a surface tissue of an eye to prevent or mitigate motion of theinner portion with respect to the optical region of the cornea duringblinking.

For treatment of presbyopia, the inner portion of the ophthalmic lenscomprises a surface extending along the inner portion comprising apresbyopia-mitigating refractive shape.

For treatment of spherical refractive error the surface extending alongthe inner portion of the ophthalmic lens comprises a shape configured tocorrect spherical refractive error.

In certain embodiments, the inner portion may be configured to correctnon-spherical refractive errors such as astigmatic error, multifocalerror, higher order aberrations, and custom optically correctivefunctions such as pin holes.

Certain embodiments provided by the present disclosure include devicescomprising an optical component and a coupling component, the opticalcomponent comprising a first material having a first modulus, and thecoupling component comprising a second material having a second modulus,wherein the first modulus is greater than the second modulus. FIG. 5shows device 500, comprising optical component 501 and couplingcomponent 502.

In certain embodiments, device 500 has a diameter 510 from about 9 mm toabout 16 mm, in certain embodiments, from about 10 mm to about 15 mm,and in certain embodiments, from about 12 mm to about 14 mm.

In certain embodiments, optical component 501 comprises a centerthickness from about 150 μm to about 500 μm, from about 200 μm to about400 μm, and in certain embodiments, from about 250 μm to about 350 μm.

In certain embodiments, optical component 501 comprises a first materialhaving a first thickness 505 and a second material having a secondthickness 503. In such embodiments, the second material may be disposedon the inner surface of optical component 501, e.g., the surface facingthe cornea, and may be the same material as the material formingcoupling component 502. The second material may have a thickness 503from about 5 μm to about 60 μm, from about 10 μm to about 50 μm, and incertain embodiments, from about 20 μm to about 40 μm. In suchembodiments, where optical component 501 comprises two materials, thetotal thickness of the optical component may be from about 100 μm toabout 550 μm, from about 200 μm to about 450 μm, and in certainembodiments, from about 250 μm to about 350 μm.

In certain embodiments, optical component 501 comprises an opticallyclear material having a modulus from about 10 MPa to about 70 MPa, fromabout 20 MPa to about 60 MPa, from about 20 MPa to about 50 MPa, and incertain embodiments from about 30 MPa to about 40 MPa.

Optical component 501 may be configured to correct vision or may not beconfigured to correct vision.

In certain embodiments, optical component 501 comprises a materialselected from silicone, silicone hydrogel, and a combination thereof. Incertain embodiments, optical component 501 comprises silicone, incertain embodiments, silicone hydrogel, and in certain embodiments acombination of silicone and silicone hydrogel.

In certain embodiments, optical component 501 comprises a centerthickness from about 150 μm to about 500 μm, a diameter from about 3 mmto about 9 mm, a radius of curvature from about 7 mm to about 12 mm, anda modulus from about 20 MPa to about 50 MPa.

In certain embodiments, coupling component 502 extends from opticalcomponent 501 to an outer periphery 504, where the thickness at thejuncture with optical component 501 is the same as or similar to that ofoptical component 502, and gradually tapers toward outer periphery 504,wherein the thickness of the coupling component at the periphery us fromabout 5 μm to about 60 μm, from about 10 μm to about 50 μm, and incertain embodiments, from about 20 μm to about 40 μm.

In certain embodiments, coupling component 502 comprises at least oneradius of curvature 512. For example, in certain embodiments, couplingcomponent 502 comprises a single radius of curvature, and in certainembodiments, coupling component 502 comprises more than one radius ofcurvature such as two, three, four, five, six, or more than six radii ofcurvature. The at least one radius of curvature can be, for example,from about 5 mm to about 15 mm, from about 6 mm to about 13 mm, fromabout 7 mm to about 12 mm, and in certain embodiments, from about 6 mmto about 10 mm. The one or more radius of curvature 512 characterizingcoupling component 502 are less than the radius of curvature of opticalcomponent 501.

In certain embodiments, coupling component 502 comprises a materialhaving a modulus from about 0.05 MPa to about 4 MPa, from about 0.1 MPato about 3 MPa, from about 0.1 MPa to about 2 MPa, and in certainembodiment from about 0.2 MPa to about 1.5 MPa.

In certain embodiments, coupling component 502 comprises a materialselected from silicone, silicone hydrogel, and a combination thereof. Incertain embodiments, coupling component comprises silicone, in certainembodiments, silicone hydrogel, and in certain embodiments a combinationof silicone and silicone hydrogel.

In certain embodiments, coupling component 502 comprises a plurality offenestrations 509 extending through the thickness of the couplingcomponent. Coupling component 502 may comprise, for example, from 1 toabout 30 fenestrations, from 1 to about 20 fenestrations, and in certainembodiments, from about 1 to about 10 fenestrations. Fenestrations 509may have any suitable shape to provide egress of tear fluid. Suitableshapes include, for example, circular, elliptical, oval, rectangular,square, slot, or combination of any of the foregoing. Each of theplurality of fenestrations 509 may have the same shape or at least someof the fenestrations may have different shapes. In certain embodiments,the fenestrations have a maximum dimension (hole size) from about 50 μmto about 700 μm, from about 100 μm to about 500 μm, and in certainembodiments, from about 200 μm to about 400 μm. Each of thefenestrations may have the same maximum dimension or at least one of thefenestrations may have a different dimension.

In certain embodiments, coupling component 502 does not includefenestrations.

In certain embodiments, coupling component 502 comprises a thicknesstapering from the thickness of optical component 501 to a thickness ofabout 30 μm at the periphery 504 of the coupling component; a pluralityor radius of curvature from about 7 mm to about 12 mm; and comprises amaterial having a modulus from about 0.1 MPa to about 2 MPa. Inembodiments in which coupling component 502 comprises a plurality ofradii of curvatures 512, the radius of curvature decreases from theoptical component toward the periphery.

The device, including optical component 501 and coupling component 502,is configured to provide a seal to a tissue of an eye such as anepithelium to thereby resist movement of the optical component on aneye.

FIGS. 6A-6C show various lenses positioned on an astigmatic eye. Foreach of FIGS. 6A-6C, the left image shows the configuration of the firstradial and the right image shows the configuration of the second radialcorresponding to the aspheric projection 608. In FIG. 6A, theconfiguration corresponding to the first radial includes the opticalsurface of the eye 601 and soft refractive lens 603, which provides afocus on retina 605. In the right image of FIG. 6A, the second radialdirection corresponds to a different refractive shape 602 that does notfocus on the retina. Soft, conformable ophthalmic lens 604 conforms toshape 602 and thereby fails to correct the non-spherical aberration.FIG. 6B shows aspheric correction using a hard, non-conformableophthalmic lens 606. Again, the first radial and the second radialcorrespond to different optical shapes 601 and 602, respectively.Although hard ophthalmic lens 606 corrects vision, the lens must beoriented to correct the asymmetric profile of the eye. FIG. 6Cschematically shows correction of non-spherical aberration usingophthalmic lenses and methods provided by the present disclosure (withthe peripheral portion of the eye and lens outside the optical regionomitted for simplicity). Ophthalmic lenses provided by the presentdisclosure have a modulus and rigidity that is configured to provide alenticular volume between the optical surface of the eye 602 and theophthalmic lens 607. For correction of presbyopia, the ophthalmic lensis configured such that the lenticular volume fills with tear fluid. Ascan be appreciated, it is not necessary to orient ophthalmic lens 607 tocorrect non-spherical optical aberrations.

Devices provided by the present disclosure may be used as platforms in anumber of ophthalmic applications including, for example, epitheliumhealing, spherical correction of astigmatism, presbyopic solutions,epithelial reshaping, and dry eye.

In certain embodiments, devices may be used to facilitate epithelialhealing. Epithelial defects can occur, for example, as the result ofPRK, filamentary keratitis, evaporative dry eye, or physical injury tothe eye. In these and other applications, including applications inwhich vision is corrected,

When positioned on the eye of a patient, the inner surface of the deviceand the outer surface of the eye, which may include, for example, thecornea, Bowman's membrane, and/or epithelium, can define a chamber tofacilitate healing and/or growth of the epithelium. In such applicationsit is desirable that a device control moisture content and exhibit ahigh Dk to facilitate extended wear. Using devices and methods providedby the present disclosure, complete epithelial regrowth following PRKsurgery can occur within about 48 hours, about 72 hours, 96 hours, andin for certain patients, within about 1 week following PRK.

When used for spherical correction of corneal astigmatism, devices andmethods provided by the present disclosure exhibit the advantages ofimproved comfort compared to gas permeable lenses, enhanced visioncompared to soft contact lenses, and reduced fitting time compared totoric and GP lenses. Devices and methods can, in certain embodiments,correct greater than 95% of astigmatic errors, irregular astigmatismsuch as induced by trauma or RK, and early kerotoconus.

In certain embodiments, a device comprises an optical component thatcorrects vision. Thus, in addition to spherical correction, the opticalcomponent can be configured to support multifocal, higher orderaberration or custom optical designs such as pin holes.

In epithelial reshaping applications, devices and methods provided bythe present disclosure can be used to reshape the epithelial duringwear, and correct vision for a period of time after the device isremoved from the eye. For example, to correct myopia, a device can beused to guide the epithelium toward the periphery of the eye and tocreate a flatter center curve. To correct hyperopia, a device may beused to guide the epithelium toward the center of the eye and to createa steeper center curve. In certain embodiments, a device can be used toinduce multifocality for vision correction by guiding the epitheliumtoward a desired location or locations on a cornea by molding with anaspheric optic. The induction of multifocality through epithelialresphaping can be useful to correct vision in presbyopia and myopia.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure are configured to correct refractive error such asastigmatism. The lenses provide a smooth spherical anterior surface andminimize lens-induced distortions by reducing flexure of the inneroptical portion and by maintaining lens centration during wear. Reducedflexure of the inner optical portion can in part be accomplished byincreasing the rigidity of the inner portion and by creating a tearlens. Centration of the inner optical portion minimizes astigmatic andprismatic effects caused by tilting of the optic and also minimizes edgedistortion.

Ophthalmic lenses provided by the present disclosure can achieve visualcorrection at least equivalent to that of soft toric contact lenses andachieve a superior comfort level compared to soft toric contact lenses.Furthermore, because the ophthalmic lenses provided by the presentdisclosure are radially symmetric, fitting to an eye of the patientinvolves only accommodating the spherical correction and an inventory oflenses for correcting cylindrical error is not required.

Ophthalmic lenses provided by the present disclosure include an inneroptic portion configured to be disposed over the optical region of thecornea and a peripheral or outer portion that is disposed radiallyoutward of the inner portion. An ophthalmic lens includes a posteriorsurface that extends along the inner portion of the lens and is adjacentan eye when applied to an eye of a patient. An ophthalmic lens alsoincludes an anterior surface that extends along the outer surface of thelens and opposite the posterior surface. In general, the inner portionof a lens is configured to improve vision and the peripheral portion isconfigured to improve comfort. However, the configuration of the innerportion can play a role in determining patient comfort, and theperipheral portion, at least in part, by maintaining centration of theinner optical portion on the optical portion of the cornea during wearenhances the visual outcome.

The inner optical portion of a lens is configured so that engagement ofthe posterior surface against the eye deforms the posterior surface sothat the posterior surface of the inner portion has a shape divergingfrom the refractive shape of the epithelium and optical portion of thecornea. The anterior surface of the inner portion of the ophthalmic lensprovides a spherical surface to correct a patient's vision.

In certain embodiments, the inner optical portion of a lens ischaracterized by a diameter from about 5 mm to about 10 mm, from about 7mm to about 9 mm, from about 7.5 mm to about 8.5 mm, from about 7.8 mmto about 8.2 mm, and in certain embodiments, about 8 mm. The anteriorinner portion of a lens is characterized by a substantially sphericalprofile without a cylindrical component. In certain embodiments, aninner portion is characterized by a thickness from about 100 μm to about900 μm, from about 200 μm to about 900 μm, from about 300 μm to about700 μm, 500 μm to 900 μm, from 550 μm to 850 μm, from 600 μm to 750 μm,from 600 μm to 800 μm, from 600 μm to 725 μm, and in certainembodiments, from 600 μm to 700 μm. In comparison, commerciallyavailable toric contact lenses for correcting refractive error arecharacterized by a thickness from about 150 μm to about 250 μm.

In certain embodiments, the inner portion comprises a first layer ofmaterial forming the posterior surface of the lens and a second layer ofmaterial forming the anterior surface of the lens. The first layer isthin and can be formed from the same material as that of the peripheralportion. In certain embodiments, first layer is from 10 μm to 60 μm,from 20 μm to 50 μm, and in certain embodiments from about 25 to about35 μm thick. The first layer retains the inner portion. In certainembodiments, an inner portion comprises a third layer overlying theanterior surface of the second layer. Again, as with the first layer,the third layer is thin, having for example a similar thickness to thatof the first layer, can be formed from the same material as the materialforming the peripheral region, and retains the second layer, which isalso referred to as the button. The second layer or button provides thebulk of the thickness of the inner portion of a lens.

The inner optical portion of a lens is characterized by a rigidity wherethe rigidity of the inner portion is greater than the rigidity of theperipheral portion of the lens. In certain embodiments, the innerportion is characterized by a rigidity from about 8E8 MPa-μm³ to about 2E10 MPa-μm³. As disclosed herein, the rigidity is a function of thethickness and the modulus of the material. Ophthalmic lenses provided bythe present disclosure employ a soft, low modulus material for the innerportion and achieve increased rigidity by increasing the cross-sectionalthickness. For example, in certain embodiments, the modulus of thematerial forming the inner optical portion is from about 10 MPa to about100 MPa. It is believed that the soft, low modulus material improvespatient comfort.

In certain embodiments, the rigidity of the inner portion of the deviceis greater than the rigidity of the outer portion. For example, incertain embodiments, a device can have an inner rigidity from about1.2E-6 Pa-m³ to about 3.1E-3 Pa-m³, from about 1E-5 Pa-m³ to about 1E-3Pa-m³, and in certain embodiments, from about 1E-4 Pa-m³ to about 1E-3Pa-m³.

In certain embodiments, a device can have an outer rigidity from about5.4E-9 Pa-m³ to about 1.5E-4 Pa-m³, from about 1E-8 Pa-m³ to about 1E-4Pa-m³, from about 1E-7 Pa-m³ to about 1E-5 Pa-m³, and in certainembodiments, from about 1E-6 Pa-m³ to about 1E-5 Pa-m³.

The rigidity of a portion of the device can be increased by increasingthe thickness of a single material, using a material having a highermodulus for the same thickness, or by combining materials havingdifferent moduli and thicknesses.

The rigidity of a portion of a device is approximated by the modulus ofthe material comprising the portion multiplied by the cube of thethickness. When a portion comprises more than one material, the rigiditycan be approximated based on the average modulus of the portionmultiplied by the thickness cubed of the portion. For example, a portioncomprising a first material with a modulus of 20 MPa and a thickness of90 μm and a second material with a modulus of 5 MPa and a thickness of10 μm will have an average modulus of 18.5 MPa. The rigidity of theportion can then be approximated by multiplying the average modulustimes the cube of the thickness, which for the present example isdetermined to be 18.5E-6 Pa-m³. Although these calculations can be basedon approximations, a person skilled in the art can conduct simulations,for example finite element modeling simulations, so as to moreaccurately estimate relative rigidity and/or can measure pressures anddeflection forces to determine rigidities of the various portions of thedevice.

In certain embodiments, an inner portion of a device is furthercharacterized by an index of refraction that may correspondsubstantially to the index of refraction of the cornea, for example theindex of refraction may be within a range from about 1.38 to about 1.43so as to match the index of refraction of the cornea to within about±0.05. In certain embodiments, the inner portion and the outer portionare characterized by an index of refraction from about 1.38 to about1.43 so as to match the index of refraction of the cornea to withinabout ±0.05.

In certain embodiments, for example, where the device provides visioncorrection, the inner portion may be characterized by an index ofrefraction that is different than the refractive index of the cornea.

In certain embodiments, an inner portion comprises an optically clearmaterial having a modulus from about 10 MPa to about 100 MPa, 10 MPa toabout 70 MPa, from about 20 MPa to about 60 MPa, from about 20 MPa toabout 50 MPa, and in certain embodiments from about 30 MPa to about 40MPa. In certain embodiments, the inner portion comprises a materialcharacterized by a modulus from about 20 MPa to about 30 MPa, from about22 MPa to about 28 MPa and in certain embodiments about 25 MPa.

In certain embodiments, the inner portion of a device comprises a singlematerial having a modulus from about 1.2 MPa to about 25 MPa, athickness from about 100 μm to about 500 μm, and a rigidity from about1.2E-6 Pa-m³ to about 3.1E-3 Pa-m³. In certain embodiments, the outerportion of a device comprises a single material having a modulus fromabout 0.2 MPa to about 1.4 MPa, a thickness from about 30 μm to about500 μm (e.g., tapering from the thickness of the inner portion), and arigidity from about 5.4E-9 Pa-m³ to about 1.5E-4 Pa-m³. In certainembodiments, the inner portion of a device comprises a single materialhaving a modulus from about 1.2 MPa to about 25 MPa, a thickness fromabout 100 μm to about 500 μm, and a rigidity from about 1.2E-6 Pa-m³ toabout 3.1E-3 Pa-m³; and the outer portion of a device comprises a singlematerial having a modulus from about 0.2 MPa to about 1.4 MPa, athickness from about 30 μm to about 500 μm (e.g., tapering from thethickness of the inner portion), and a rigidity from about 5.4E-9 Pa-m³to about 1.5E-4 Pa-m³.

In certain embodiments, an inner portion comprises a material selectedfrom silicone, silicone hydrogel, a hydrogel, and a combination of anyof the foregoing. In certain embodiments, an inner portion comprisessilicone, in certain embodiments, silicone hydrogel, in certainembodiments, a hydrogel, and in certain embodiments a combination ofsilicone and silicone hydrogel.

FIG. 7 shows a cross-section view of a device according to certainembodiments of the present invention. The device shown in FIG. 7 has aleast a tri-curve profile including a central curvature, a mid-peripherycurvature, and a peripheral curvature. The central curvature refers tothe curvature of the inner portion of the device spanning anapproximately 3 mm diameter region in the center of the device. Themid-periphery curvature refers to the curvature in a radial region about5 mm from the center of the device. The peripheral curvature refers tothe curvature toward the edge of the device. In certain embodiments, asshown for example in FIG. 7, the transition from the peripheralcurvature region to other parts of the device may not be smooth and maybe characterized by an angle. FIG. 7 shows a centerline 701 of devices700 provided by the present disclosure, having a central region 702 andmid-peripheral regions 704 on either side of the central region 702. Incertain embodiments, the diameter 703 of central region 702 is fromabout 5 mm to about 7 mm, from about 5.5 mm to about 6.5 mm, and incertain embodiments is about 6 mm. In certain embodiments, themid-peripheral regions 704 extend form the edge diameter of centerregion 702 to about 5 mm from centerline 701. Accordingly, the diameterof the mid-peripheral region can be from about 7 mm to about 11 mm, fromabout 7 mm to about 10 mm, from about 6.5 mm to about 11 mm, from about6.5 mm to about 10 mm, and in certain embodiments, from about 6 mm toabout 10 mm. In certain embodiments, the peripheral diameter 707 of adevice can be from about 11 mm to about 16 mm, from about 12 mm to about15 mm, and in certain embodiments, about 14 mm. As referred to herein,the outer portion comprises the mid-peripheral regions, which are alsoreferred to as intermediate portions, and the peripheral portion.

In certain embodiments, an outer portion comprises a material having amodulus from about 0.05 MPa to about 4 MPa, from about 0.1 MPa to about3 MPa, from about 0.1 MPa to about 2 MPa, and in certain embodiment fromabout 0.2 MPa to about 1.5 MPa. In certain embodiments, the outerportion comprises a material characterized by a modulus from about 0.9MPa to about 1.5 MPa, from about 1 MPa to about 1.4 MPa, and in certainembodiments, about 1.2 MPa. In certain embodiments, the material formingthe peripheral portion is characterized by a modules from about 0.01 MPato about 10 MPa, from about 0.01 MPa to about 8 MPa, from about 0.01 MPato about 5 MPa, and in certain embodiments, from about 0.01 MPa to about2 MPa. In certain embodiments, a device comprises an inner portionformed from a material such as a silicone polymer, silicone hydrogel, orhydrogel characterized by a modulus of about 25 MPa, and an outerportion formed from a material such as a silicone polymer or siliconehydrogel characterized by a modulus of about 1.2 MPa.

In certain embodiments, an outer portion comprises a material selectedfrom silicone, silicone hydrogel, a hydrogel, and a combination of anyof the foregoing. In certain embodiments, coupling component comprisessilicone, in certain embodiments, silicone hydrogel, a hydrogel, and incertain embodiments a combination of silicone, silicone hydrogel, and/ora hydrogel.

In certain embodiments, the material forming a device including both theinner and outer portions have low water content and is characterized bylow water or ion permeability. In certain embodiments, the water contentis less than about 5%, less than about 4%, and in certain embodiments,less than about 3%. In certain embodiments, the material forming adevice has a water content less than about 1%, less than about 0.6%, andin certain embodiments, less than about 0.3%. In certain embodiments,the material less than about 0.4×10⁻⁶ cm²/sec, less than about 0.2×10⁻⁶cm²/sec, and in certain embodiments, less than about 0.1×10⁻⁶ cm²/sec.

In certain embodiments, the inner portion comprises a different materialthan the outer portion. In certain embodiments, the inner portion andthe outer portion comprise the same material. In embodiments in whichthe inner portion and the outer portion comprise the same material, thedifferent moduli may be realized by the detailed chemistry of thepolymer used, such as characterized by different crosslinking densities.

In certain embodiments, the inner portion of a device and the outerportion of a device comprise a first material characterized by a firstmodulus and extending along a lower surface of the device; and the innerportion comprises a second material characterized by a second modulusdisposed anteriorly to the first material, the second modulus beinggreater than the first modulus. In such embodiments, the first materialis a thin layer that is configured to promote comfort of the device whenapplied to the cornea by cushioning between the anterior surface of thecornea and the layer of the first material. The second material isconfigured to promote a beneficial optical shape of an anterior surfaceof the applied device over the eye.

As a measure reflecting the rigidity of the inner portion, the flexureof the inner portion can be determined using the ISO 18369-4 flexuretest method. The flexure of inner portions or buttons was determined forvarious thicknesses of a silicone material having a modulus of about 25MPa.

A peripheral portion is radially disposed radially outward of the innerportion of an ophthalmic lens. In general, the peripheral portionretains the inner portion and is characterized by approximately the samethickness as the inner portion at the interface between the inner andperipheral portions, and the thickness of the peripheral portion taperstoward the peripheral edge. In certain embodiments, the diameter of theperipheral edge is from about from about 12 mm to 16 mm, 13 mm to about16 mm, from about 13.5 mm to about 15.5 mm, from about 14 mm to about 15mm, and in certain embodiments, from about 14.2 mm to about 14.8 mm.

The peripheral portion is characterized by a lower rigidity than theinner portion and can be formed from a material having a lower modulusthan that of the inner portion. In certain embodiments, the materialforming the peripheral portion is characterized by a modulus from about0.5 MPa to about 2.0 MPa, from about 0.8 MPa to about 1.7 MPa, fromabout 1.0 MPa to about 1.4 MPa, and in certain embodiments, about 1.2MPa.

The peripheral portion is configured to provide tear flow between theanterior surface of the device and the epithelium. In certainembodiments, the peripheral portion comprises a plurality offenestrations extending from the anterior to the posterior surface ofthe peripheral portion. In certain embodiments, the plurality offenestrations are disposed at a radius from a central optical axis ofthe ophthalmic lens such as for example, at a radius proximate to theinterface between the inner portion and the peripheral portion. Theplurality of fenestrations may be symmetrically or asymmetricallydisposed. The fenestrations may be configured to pump tear liquidbetween the peripheral portion and the epithelium when the eye blinks soas to maintain a tear layer between the posterior surface of the lensand the epithelium and/or across the anterior surface of the lens. Incertain embodiments, the plurality of fenestrations may be configured tofacilitate removal of the lens from the eye. In certain embodiments, theplurality of fenestrations may be configured to facilitate airdissipation if air bubbles are trapped underneath the lens, In certainembodiments, the plurality of fenestrations facilitates the removal ofair bubble entrapped within any lenticular volumes following applicationof a lens to a patient's eye. The plurality of fenestrations mayfacilitate both removal of the lens form the eye and dissipation of airbubbles. In certain embodiments, the plurality of fenestrations improvesthe reproducibility of visual outcome in a population of patientswearing the lens compared to the visual outcome in a population ofpatients wearing a comparable lens without fenestrations.

In certain embodiments, the inner portion, the peripheral portion, orboth the inner and peripheral portions of an ophthalmic lens provided bythe present disclosure are radially symmetric. In certain embodiments,the anterior surface of the inner portion and the posterior surface ofthe inner portion are radially symmetric.

In certain embodiments of ophthalmic lenses provided by the presentdisclosure, the inner portion and the peripheral portion are configuredto allow movement of the lens relative to the eye in response toblinking of the eye. In such embodiments, an ophthalmic lens isconfigured such that the inner optical portion centers on the opticalportion of the cornea following blinking. During blinking the innerportion, the peripheral portion, or both the inner and peripheralportions may deform and/or move with respect to the center optical axisof the cornea. When an ophthalmic lens is worn by a patient, dependingat least in part by the shape of the patient's eye and the configurationof the lens, the ophthalmic lens may move during blinking or may exhibitonly micro-movement. However, in certain embodiments, a lens is notconfigured to resist movement such that, for example, the peripheraledge of the lens is not configured to fixedly engage the epithelium orsclera such that the inner portion resists movement relative the cornea.

In certain embodiments of ophthalmic lenses provided by the presentdisclosure, the inner portion and the peripheral portion are configuredto provide a tear fluid flow between the peripheral portion of theophthalmic lens and the epithelium.

In certain embodiments, an ophthalmic lens provided by the presentdisclosure includes a reinforcement ring disposed toward the interfacebetween the inner portion and the peripheral portion. FIGS. 15A and 15Bshow perspective and cross-sectional views of an ophthalmic deviceprovided by the present disclosure incorporating a reinforcement ring.FIGS. 15A and 15B show an ophthalmic lens having a central optic portion1501, a peripheral portion or skirt 1502, mechanically coupled to theinner portion 1501, in part by thin layer 1506 disposed along theposterior surface of the inner portion. Inner portion 1501 ischaracterized by a substantially uniform thickness 1507 and a rigiditythat is greater than the rigidity of peripheral portion 1502. Peripheralportion 1502 includes a heal 1505 and a peripheral edge 1504.Reinforcement ring 1503 is disposed toward the interface between thecentral optic portion 1501 and the peripheral portion 1502 and in theembodiment shown in FIGS. 15A and 15B the reinforcement ring 1503 isembedded within central optic portion 1501. In FIG. 15A the differentelevations of the central optic portion and the peripheral portion areintended to show that these portions may have one or more radius ofcurvature. A reinforcement ring may be disposed or embedded within theinner portion, disposed or embedded within the peripheral portion, ordisposed at the interface between the inner and peripheral portions. Areinforcement ring is configured to prevent or minimize flexure of theinner optic portion from forces on the eye and/or forces of the eye lidssuch as during blinking. A reinforcement ring is disposed at a radiallocation such that the ring does not interfere with vision. Areinforcement ring may be a radially symmetric ring and can beconfigured to facilitate centering of the ophthalmic lens on the opticalregion of the cornea during wear. In certain embodiments, areinforcement ring may be made from a material having a higher modulusthan that of the materials forming the inner portion and the peripheralportion of the lens. In certain embodiments, a reinforcement ring may bemade from a rigid, optically opaque or translucent material such as, forexample, polyimide, polyether ether ketone, polyetherimide, polysulfone,polyether sulfone, polycarbonate, silicone-acrylate,fluorosilicone-acrylate, or a combination of any of the foregoing. Incertain embodiments, a reinforcement ring may be made of a transparentrigid gas permeable polymer such as, for example,polymethylmethacrylate, fluorosilicone acrylate, a silicone acrylate ora combination of any of the foregoing. In certain embodiments, areinforcement ring may be made from a metal such as, for example,titanium, stainless steel, cobalt steel, or a combination of any of theforegoing. In certain embodiments, the material forming thereinforcement ring has the same index of refraction as that of thematerial forming the inner portion. In certain embodiments, areinforcement ring may have, for example, an inner diameter from about 4mm to about 12 mm, from about 6 mm to about 12 mm, from about 8 mm toabout 12, and in certain embodiments, from about 8 mm to about 10 mm. Incertain embodiments, a reinforcement ring may have, for example, a widthfrom about 0.1 mm to about 5 mm, from about 1 mm to about 4 mm, fromabout 2 mm to about 3 mm, and in certain embodiments, from about 0.5 mmto about 2 mm. In certain embodiments, a reinforcement ring may have,for example, a thickness from about 0.05 mm to about 0.5 mm, from about0.1 mm to about 0.4 mm, from about 0.2 mm to about 0.3 mm, and incertain embodiments from about 0.2 mm to about 0.4 mm. A reinforcementring may or may not include features to enhance adhesion of the ring tothe material forming the center optic portion and/or the materialforming the peripheral portion of the lens. For example, a reinforcementring may include concave and/or convex surfaces, indentations, partialthrough-holes, full through-holes, perforations, serrated or irregularedges, or a combination of any of the foregoing.

The peripheral portion of a lens can be tapered toward the peripheraledge. The taper may be continuous or discontinuous. The peripheralportion may be flared outward toward the peripheral edge and is referredto as a modified heeled configuration. A cross-sectional profile of alens is determined by the inner portion characterized by a substantiallyconstant thickness and the shape of the taper of the peripheral portion.Examples of cross-section lens profiles are shown in FIGS. 14A-14C. Ingeneral, the cross-sectional shape of an ophthalmic lens is configuredto correct refractive error of any eye, center the lens on the opticalportion of the cornea, facilitate motion of the lens with respect to theeye, provide flow of tear liquid between the posterior surface of thelens and epithelium, and to provide comfort to a patient wearing thelens. The ability of the lens to move, provide a fluid layer, andexchange tear fluid facilitates eye health and improves comfort forextended wear.

The flexure of the inner portion of lenses provided by the presentdisclosure is presented in Table 1. Table 1 provides the force (gm)required to flex an inner portion having thicknesses from 200 μm to 850μm a certain percent of the un-flexed diameter. For thicknesses of 200μm, 325 μm, and 550 μm, the force required to displace the inner portionby 1% was too small for the instrument to measure accurately. Theresults for a 150 μm-thick inner portion of a standard RGP toric lensand for a 250 μm-thick hybrid toric lens, used to correct refractiveerror are also presented in Table 1. As is shown by the resultspresented in Table 1, significantly more force is required to flex thetoric lenses than ophthalmic lenses provided by the present disclosurehaving a similar thickness. This is at least in part the consequence ofthe toric lenses being made of a material having a much higher modulusthan that of the present design.

TABLE 1 Thickness Force (gm) to flex Lens Design (μm) 1% 10% 20% NXVRigid 200 N/A 1.2 1.6 Silicone 325 N/A 4.9 6.7 550 N/A 20 25 600 8 35 36725 15 65 69 850 20 101 96 RGP 150 6.4 29 39 Soft Toric 250 16 116 167

In certain embodiments, the force required to flex the inner portionusing the ISO 18369-4 flexure test method by 1% is from about 0.5 gm toabout 50 gm, from about 1 gm to about 40 gm, and in certain embodiments,from about 5 gm to about 25 gm.

In certain embodiments, the inner portion is characterized by a rigidityfrom about 5.0E10 Pa-μm³ to about 5.0E8 Pa-μm³, 2.0E10 MPa-μm³ to about8E9 MPa-μm³, from about 1.8E10 MPa-μm³ to about 8.5E9 MPa-μm³, fromabout 1.6E10 MPa-μm³ to about 8.8E9 MPa-μm³, and in certain embodiments,from about 1.5E10 MPa-μm³ to about 9E9 MPa-μm³. In certain of suchembodiments, the thickness of the inner portion is from about 650 μm toabout 850 μm, in certain embodiments, from 200 μm to 800 μm, and incertain embodiments, from 400 μm to 800 μm. And, in certain of suchembodiments, the modulus of the material forming the inner portion isfrom about 20 MPa to about 30 MPa, from about 23 MPa to about 27 MPa,and in certain embodiments, about 25 MPa. This can be compared to softtoric lenses having a central optic thickness of about 70 μm, a modulusof 1.7 MPa, and a rigidity of about 5.8E5 MPa-μm³. This can also becompared to a RGP lens having a center optic thickness of 150 μm, amodulus of 1,200 MPa and rigidity of 4E9 MPa-μm³. Compared to a softtoric lens, in certain embodiments, ophthalmic lenses provided by thepresent disclosure have a relative rigidity of the central optic portionthat is from about 10,000 to 30,000 times greater than the rigidity ofthe central portion of a soft toric lens.

In certain embodiments, the inner portion is characterized by a rigidityfrom 4E8 MPa-μm³ to 1E10 MPa-μm³, from 6E8 MPa-μm³ to 1E10 MPa-μm³, from8E8 MPa-μm³ to 1E10 MPa-μm³, from 1E9 MPa-μm³ to 1E10 MPa-μm³ from 2E9MPa-μm³ to 1E10 MPa-μm³, from 4E9 MPa-μm³ to 1E10 MPa-μm³, and incertain embodiments, from 6E9 MPa-μm³ to 1E10 MPa-μm³. In certain ofsuch embodiments, the thickness of the inner portion is from about 100μm to 900 μm, in certain embodiments, from 200 μm to 800 μm, and incertain embodiments, from 400 μm to 800 μm. And, in certain of suchembodiments, the modulus of the material forming the inner portion isfrom about 20 MPa to about 30 MPa, from about 23 MPa to about 27 MPa,and in certain embodiments, about 25 MPa.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure are characterized by a center rigidity of at least about 6E9MPa-μm³, at least about 8E9 MPa-μm³, at least about 1E10, at least about1.2E10 MPa-μm³ and in certain embodiments, at least about 1.4E10MPa-μm³. The center rigidity can be selected based on the modulus andthickness of the material or materials used to form the center opticalportion of a lens. In general, the rigidity of the central portion of alens is selected to maintain a spherical anterior surface during use. Incertain embodiments, the thickness of the center of the optical portionis at least 200 μm, at least 300 μm, at least 400 μm, at least 500 μm,at least 600 μm, at least 700 μm, and in certain embodiments at least800 μm. In certain embodiments, the thickness of the center of theoptical portion is from 100 μm to 900 μm, from 200 μm to 900 μm, from300 μm to 900 μm, from 400 μm to 900 μm, from 500 μm to 900 um, from 600μm to 700 μm, from 700 μm to 800 μm, and in certain embodiments at least300 μm to 600 μm. In general, lenses with a thinner central thicknessare more comfortable to wear. In certain embodiments, the inner portionof an ophthalmic lens is formed from a material characterized by amodulus less than 1,000 MPa, less than 750 MPa, less than 500 MPa, lessthan 250 MPa, less than 200 MPa, less than 100 MPa, less than 50 MPa,less than 30 MPa, less than 20 MPa, and in certain embodiments, lessthan 10 MPa. In certain embodiments, an ophthalmic lens is characterizedby a center rigidity of at least about 6E9 MPa-μm³, a thickness from 200μm to 900 μm, and a modulus from 10 MPa to 1,000 MPa, and in certainembodiments a modulus from 10 MPa to 200 MPa.

In certain embodiments, an inner optic portion is characterized by athickness from 100 μm to 900 μm, by a modulus from about 10 MPa to about1,000 MPa, and a rigidity of at least about 4E8 MPa-μm³. In certainembodiments, an inner optic portion is characterized by a thickness from100 μm to 900 μm, by a modulus from about 10 MPa to about 600 MPa, and arigidity of at least about 4E8 MPa-μm³. In certain embodiments, an inneroptic portion is characterized by a thickness from 100 μm to 900 μm, bya modulus from about 10 MPa to about 300 MPa, and a rigidity of at leastabout 4E8 MPa-μm³. In certain embodiments, an inner optic portion ischaracterized by a thickness from 100 μm to 900 μm by a modulus fromabout 10 MPa to about 100 MPa, and a rigidity of at least about 4E8MPa-μm³.

In certain embodiments, an inner portion of an ophthalmic lens ischaracterized by a center rigidity of at least about 1E9 MPa-μm³, athickness from 100 μm to 800 μm, and a modulus from 10 MPa to 800 MPa,and in certain embodiments a modulus from 10 MPa to 200 MPa. In certainembodiments, an ophthalmic lens is characterized by a center rigidity ofat least about 5E8 MPa-μm³, a thickness from 100 μm to 800 μm, and amodulus from 10 MPa to 800 MPa, and in certain embodiments a modulusfrom 10 MPa to 200 MPa.

In certain embodiments and depending at least in part on the shape of apatient's cornea, the posterior surface of an ophthalmic lens may notcompletely conform to the surface of the epithelium during wear. Thus,at least a portion of the inner portion, the peripheral portion, or boththe inner and peripheral portions by form a vault over at least certainportions of the underlying epithelium to form one or more lenticularvolumes. The lenticular volumes may be filled with tear liquid. Theability of the lens to move on the eye during blinking and anyfenestrations if present can circulate tear fluid the lenticular volumeand exchange tear fluid with other parts of the eye.

In certain embodiments, the inner portion and the peripheral portion areformed from silicone, a silicone hydrogel, a hydrogel, or a combinationof any of the foregoing.

FIG. 8A shows the average spherical lens corrected visual acuity (LogMAR) in a population of patients having uncorrected 1.25DC to 2.00DCcylindrical error (low to moderate astigmatism) when wearing a lens ofthe present disclosure. The average spherical lens visual acuity (LogMAR) for each thickness of lens is shown above the minimum and maximumvalues. The number of patients tested is also indicated in the figure.Soft toric contact lenses suitable for correcting low to moderateastigmatism provide 20/20 vision (Toric SCL) 0.00 Log MAR with astandard deviation of ±0.15 (±1 SD). Similar corrected visual acuitiesare obtained with lenses provided by the present disclosure in which thethickness of the inner portion is from 600 μm to 800 μm and a modulus of25 MPa. As reflected by the minimum and maximum for the lenses providedby the present disclosure, the deviation in the corrected visualacuities are less than those for the toric soft contact lens producttested.

The results presented in FIG. 8A are represented in a different formatin FIG. 8B to show the percent of patients having equal to or betterthan 20/25 vision or having equal to or better than 20/20 vision whenwearing a lens having a central thickness of 600 μm, 725 μm, or 850 μm,provided by the present disclosure. Prior to wearing the lens, thepatients had an uncorrected cylindrical error from 1.25DC to 2.00DC. Asshown in FIG. 8B, 100% of patients had 20/25 vision or better for eachthickness tested. Also, the percent of patients seeing 20/20 or betterincreased with the thickness of the inner portion of the lens.

In certain embodiments, devices for correcting refractive error inpatients having low to moderate astigmatism corresponding to anuncorrected cylindrical error from about 1.25DC to about 2.00DC whenworn by a patient provide at least 20/25 vision or 20/20 vision.

FIG. 9A and FIG. 9B show results similar to those provided in FIG. 8Aand FIG. 8B for patients having uncorrected cylindrical error of 2.25DCto 3.00DC consistent with moderate to high astigmatism. The averagespherhical lens visual acuity (Log MAR) for each thickness of lens isshown above the minimum and maximum of the measure values. The number ofpatients tested is also indicated in the figure. For patients withmoderate to high astigmatism, soft toric lenses provide an averagespherical lens corrected visual acuity (Log MAR) of 0.15±0.15 (±1 SD).As shown in FIG. 9A, ophthalmic lenses provided by the presentdisclosure having a central thickness from 600 μm to 850 μm and amodulus of 25 MPa provide an average spherical lens corrected visualacuity that is equivalent to or better than that of the tested toricsoft contact lens. The histogram in FIG. 9B shows that for patientshaving moderate to severe astigmatism, the percent of patients seeing20/25 or better and 20/20 increases with increasing thickness of theinner portion of the lens.

In certain embodiments, devices for correcting refractive error inpatients having moderate to high astigmatism corresponding to anuncorrected cylindrical error from about 2.25DC to about 3.00DC whenworn by a patient provide at least 20/25 vision or 20/20 vision.

In certain embodiments, when wearing an ophthalmic lenses provided bythe present disclosure an average corrected visual acuity in apopulation of patients having from 2.25DC to 3.00DC cylindrical error is0.1±0.15 Log MAR or better.

In certain embodiments, when wearing an ophthalmic lenses provided bythe present disclosure an average corrected visual acuity in apopulation of patients having from 1.25DC to 2.00DC cylindrical error is0.0±0.15 Log MAR or better.

Ophthalmic lenses provided by the present disclosure are configured toprovide refractive correction equivalent to or better than RGP and softtoric lens, and to provide enhanced comfort. The comfort of lensesprovided by the present disclosure is compared to that of commerciallyavailable soft toric contact lenses in FIG. 10A. A comfort score wasdetermined by asking patients to rate the level of comfort experiencedwhile wearing a particular lens on a scale from 1 to 10 with a score of10 reflecting extreme comfort. The average comfort score for eachthickness of lens is shown above the error bars for ±1 SD. The number ofpatients tested is also indicated in the figure. The average (±1 SD)comfort scores for patients wearing lenses of the present disclosurehaving an inner thickness from 275 μm to 850 μm are compared with thecomfort score for five (5) different soft toric contact lens designsA-E. The results for the present lenses were obtained within 30 minutesafter a lens was applied to an eye. For a 275 μm-thick lens, the comfortwas also determined at the end of one day. The results for the softtoric contact lens were determined either one week or at the end of oneday following application to the eye. The best soft toric contact lensprovided a mean comfort score of 8.3 (±1.12) after one week of wearing.The lenses provided by the present disclosure provided an enhancedcomfort score with thinner lenses exhibiting greater comfort.

In certain embodiments, devices for correcting refractive error exhibita mean comfort level in a population of patients of at least 6.5, atleast 7.5, at least 8, or at least 9 following wearing the device for atleast one day or for at least one week. In certain embodiments, devicesfor correcting refractive error exhibit a mean comfort level in apopulation of patients of at least 6.5, at least 7.5, at least 8, or atleast 9 following wearing the device for at least 30 minutes. Thecomfort scale is based on a scale from 0 to 10 where 10 is the highestcomfort level corresponding to a patient not wearing a lens.

The percent of patients experiencing a comfort level equal to or greaterthan 8 or a comfort level equal to or greater than 9 for inner regionthicknesses of 600 μm, 725 μm, and 850 μm are presented in FIG. 10B. Theresults generally demonstrate that the percent of patients experiencinghigh comfort increases for lenses having a thickness around 725 μm andless.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure do not increase the risk of contact lens-related adverseevents such as corneal ulcers, microbial keratitis, and iritis.

FIG. 11 is a schematic diagram of instrumentation for testing theflexure of an inner portion or button of a contact lens consistent withISO 18369-4.

FIG. 12 is a graph showing the relationship between thickness andflexure for certain ophthalmic lenses provided by the presentdisclosure. The force (gm) required to flex a central portion or buttonof a lens having a thickness from 200 μm to 800 μm by 10% is shown inFIG. 12.

FIG. 13 is a histogram showing the force (gm) required to flex an innerportion or button of a lens by 1%. The flexure of lenses provided by thepresent disclosure (NXV) having a central thickness from 600 μm to 850μm is compared to the flexure of a rigid gas permeable (RGP) lens and asoft toric contact lens (A) used for treating astigmatic error.

Devices and methods provided by the present disclosure can also be usedto address dry eye. In such applications, the device material comprisesa material such as silicone that has a low water content and low waterabsorption, water evaporation from the eye can be controlled and a tearor lubricant reservoir maintained.

Ophthalmic lenses provided by the present disclosure include featuresintended to confer attributes of benefit to a person wearing the lens.For example, the semi-rigid inner optic portion provides a nearspherical anterior surface and maintains the intended near sphericalcurvature during wear. By minimizing toricity and irregularities of theanterior surface of the lens and minimizing flexure, the lens providesgood vision. Vision and health of the eye are enhanced by the presenceof fenestrations. Furthermore, the semi-rigid inner optic portion issufficiently flexible to accommodate a range of corneal curvatures andis able to mask corneal toricity by forming a lenticular tear volumebetween the posterior surface of the lens and the cornea.

The fenestrations provide a supply of fluid between the posteriorsurface of the lens and the epithelium of the eye to maintain a tearlayer, which supports the intended curvature of the lens to provide goodvision. Fenestrations also maintain eye health by allowing for rapidtear exchange to circulate metabolic waste and to transmit oxygen to thetear layer. Fenestrations also prevent a lens from creating vacuum sealto the eye, allowing the lens to move on the eye and facilitating lensremoval.

The materials forming the inner optic portion and the outer peripheralportion have a low Young's modulus that improves patient comfort. Also,a thickness of a material along the posterior surface of the inner opticportion having a Young's modulus less than the modulus of the materialforming the inner optic portion may provide additional comfort. Inaddition to the effect of the fenestrations, eye health is furtherenhanced by the use of silicones and/or silicone hydrogels to form thelens. Silicones and/or silicone hydrogels are physiologically compatibleand can provide high oxygen permeability and ion permeability.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure include a plurality of fenestrations. The fenestrations canprovide a supply of tear fluid to establish and maintain a tear volumebetween the posterior surface of the inner optic portion and the corneato support the intended lens curvature, allow exchange of tear fluid tocirculate metabolic waste, and to supply and maintain a high oxygencontent at the surface of the cornea.

Fenestrations can be disposed within the inner optic portion of theophthalmic lens, within the peripheral portion of the ophthalmic lens,or within both the inner optic and peripheral portions of the ophthalmiclens. In certain embodiments, the fenestrations may be disposed alongone or more rings situated at a radius from the central axis of theophthalmic lens. Each ring may include from one (1) to twenty (20)fenestrations. In certain embodiments, fenestrations may be disposedalong one or more rings disposed at different radii from the centralaxis of the ophthalmic lens.

For example, in certain embodiments the plurality of fenestrations isdisposed at a combination of a first radius, a second radius, a thirdradius, and a fourth radius from a central optical axis of theophthalmic lens, wherein: the first radius is disposed within the inneroptic portion and from 0.5 mm to 1.0 mm from an interface between theinner optic portion and the peripheral portion; the second radius isdisposed within the peripheral portion and from 0.5 mm to 1.5 mm fromthe interface between the inner optic portion and the peripheralportion; the third radius is disposed within the peripheral portion andfrom 1.5 mm to 2.5 mm from the interface between the inner optic portionand the peripheral portion; and the fourth radius is disposed within theperipheral portion and from 0.5 mm to 2.5 mm from an edge of theperipheral portion.

An example of an ophthalmic lens provided by the present disclosure isshown in FIG. 16, which shows the disposition of fenestrations in fourrings disposed at different radial distance from the center axis of theophthalmic lens. Other configurations of the fenestrations are includedwithin the scope of the invention.

FIG. 16 shows an ophthalmic lens 1600 having an inner optic portion 1601and a peripheral portion 1602 disposed radially outward of the inneroptic portion 1601. Interface 1603 denotes the boundary between theinner optic portion 1601 and the peripheral portion 1602. Outerperipheral portion 1602 includes outer edge 1604 of the ophthalmic lens.As shown in FIG. 16, a plurality of fenestrations may be disposed withinthe inner optic portion, within the peripheral portion, or both theinner optic portion and the peripheral portion of the ophthalmic lens.At least some of the fenestrations 1605 may be disposed within the inneroptic portion of the lens proximate the interface 1603. In certainembodiments, fenestrations within the inner optic portion are disposedat a location that is not coincident with the optical region of thecornea such that the fenestrations do not interfere with vision. Incertain embodiments, at least some of the fenestrations 1606 may bedisposed within the peripheral portion proximate the interface 1603. Incertain embodiments, at least some of the fenestrations 1607 may belocated at one or more positions within a middle of the peripheralportion and/or at least some of the fenestrations may be locatedproximate the peripheral edge 1604 of ophthalmic lens. In FIG. 16, thefenestrations are shown as being located at specific radii from thecenter of the ophthalmic lens; however, the locations shown in FIG. 16are only examples.

In certain embodiments, an ophthalmic lens may comprise anywhere from 1to 20 fenestrations. The location and cross-section of certainfenestrations may be configured to pump tear liquid between theposterior surface of the lens and the epithelium when the eye blinks.Circulation of tear fluid can help to maintain eye health. Certainfenestrations may be configured to maintain a tear layer between the eyeand one or more portions of the posterior surface of the inner opticportion. The tear layer can help to maintain health of the eye, can helpto provide comfort, and can facilitate removal of the lens from the eye.Certain portions of an ophthalmic lens may conform to the cornea whileother portions may create one or more lenticular volumes between theposterior surface of a lens and the cornea. Certain fenestrations can beconfigured to maintain tear fluid within the lenticular volumes. Thelenticular volumes in conjunction with the ophthalmic lens form a tearlens for improving vision. Fenestrations located proximate to theinterface between the inner optic portion and the peripheral portion mayserve to maintain tear fluid within lenticular volumes. Certainfenestrations such as those located within the peripheral portion may beconfigured to maintain eye health and to facilitate removal of the lensfrom the eye.

In certain embodiments, a plurality of fenestrations is disposed withinthe inner optic portion to provide for sufficient tear flow beneath theinner optic portion to establish and maintain a lenticular tear volumebetween the posterior surface of the inner optic portion and the cornea.The tear volume maintains the spherical shape of the lens on the eye toimprove patient vision. While certain portions of the posterior surfaceof the lens can conform to the surface of the cornea, where the corneais characterized by toric and/or cylindrical irregularities, the inneroptic portion is sufficiently rigid that it bridges the cornealirregularities creating a lenticular volume which is filled with tearfluid.

The number and location of the fenestrations can be configured toachieve one or more of these benefits.

In certain embodiments, the tear volume beneath certain portions of theinner optic portion of the ophthalmic lens can be maintained byfenestrations located just outside the diameter of the inner opticportion of the lens.

Fenestrations located within the peripheral portion of the lens canmaintain eye health, provide tear film that facilitates motion of thelens on the cornea, and/or facilitate removal of the lens from the eye.

Fenestrations may be any suitable shape, be situated and any suitableorientation with respect to the cross-sectional profile of the lens. Incertain embodiments, fenestrations are characterized by a circularcross-section having a diameter from about 50 μm to about 300 μm, fromabout 80 μm to about 250 μm, and in certain embodiments, from about 100μm to about 200 μm.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure include a sag height from about 3 to about 5, in certainembodiments, from about 3.5 to about 4.5, and in certain embodiments,from 3.5 to about 4.2. The sag height refers to the distance from thecenter of the lens to a line extending from the peripheral edge of alens. For a particular optic curvature, lenses may be provided withseveral different sag heights to accommodate different eyeball sizesamong a general population of patients. For example, lenses havingparticular optic curvature may be provided with three different sagheights from a nominal sag height of 4.0 in steps from about 0.15 to0.3. For example, for lenses having a particular optic curvature, lenseshaving sag heights of 3.7, 4.0, and 4.3 can be provided. In certainembodiments, for lenses having a particular optic curvature, lenseshaving sag heights of 3.85, 4.0, and 4.15; sag heights of 3.8, 4.0, and4.2; and in certain embodiments, sag heights of 3.75, 4.0, and 4.25, canbe provided.

To enhance comfort, ophthalmic lenses provided by the present disclosuremay include a thickness of a material having a low Young's modulusdisposed on the posterior surface of the inner optic portion of thelens. The thickness may be less than about 50 μm, less than about 40 μm,less than about 30 μm, less than about 20 μm, and in certainembodiments, less than 10 μm. The material forming the thin layer or webmay have a Young's modulus from about 0.01 MPa to about 10 MPa Thematerial forming the thin layer underlying the inner optic portion maybe the same as or different than the material forming the peripheralportion of the ophthalmic lens.

In certain embodiments, the thin layer or web underlying the inner opticportion may comprises a material selected from silicone, siliconehydrogel, a hydrogel, and a combination of any of the foregoing.

In certain embodiments, an ophthalmic lens for correcting a refractiveerror of an eye, the eye having a cornea with a refractive shapeextending across an optical region of the eye, comprises: an inner opticportion configured to be disposed over the optical region of the cornea;a posterior surface extending along the inner optic portion adjacent theeye when the inner portion is disposed over the optical region, theinner optic portion configured so that engagement of the posteriorsurface against the eye deforms the posterior surface and so that theposterior surface has a shape diverging from the refractive shape of thecornea; a peripheral portion of the ophthalmic lens disposed radiallyoutward of the inner optic portion; and an anterior surface of theophthalmic lens extending along the inner optic portion opposite theposterior surface configured to mitigate the refractive error; wherein,the inner optic portion is characterized by an inner rigidity and theperipheral portion is characterized by a peripheral rigidity; the innerrigidity is greater than the outer rigidity; and the inner rigidity isfrom about 1E6 MPa-μm³ to about 1E11 MPa-μm³. In certain embodiments,the inner rigidity is from about 1E7 MPa-μm³ to about 1E11 MPa-μm³, fromabout 1E8 MPa-μm³ to about 1E11 MPa-μm³, from about 1E6 MPa-μm³ to about1E10 MPa-μm³, from about 1E6 MPa-μm³ to about 1E9 MPa-μm³, and incertain embodiments, from about 1E6 MPa-μm³ to about 1E8 MPa-μm³.

In certain embodiments of an ophthalmic lens, the inner optic portioncomprises a material having a modulus from about 10 MPa to about 150 MPaand the peripheral portion comprises a material having a modulus fromabout 0.01 MPa to about 10 MPa.

In certain embodiments, an inner optic portion is characterized by aninner rigidity and the peripheral portion is characterized by aperipheral rigidity, where the inner rigidity is greater than the outerrigidity; and the inner rigidity is from about 1E6 MPa-μm³ to about 1E11MPa-μm³. In certain embodiments, the inner optic portion comprises amaterial having a modulus from about 10 MPa to about 150 MPa and theperipheral portion comprises a material having a modulus from about 0.01MPa to about 10 MPa.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion comprise a material selected from silicone,silicone hydrogel, a hydrogel, or a combination of any of the foregoing.

In certain embodiments of an ophthalmic lens, the inner optic portion ischaracterized by a substantially spherical profile.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion are characterized by a water content lessthan about 5%.

In certain embodiments of an ophthalmic lens, the refractive error ofthe eye includes a cylindrical error; and the inner optic portion ischaracterized by a substantially spherical surface so that correction ofthe cylindrical error by the lens is primarily effected by thedivergence of the shape of the inner optic portion from the refractiveshape of the cornea.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion are configured to allow movement relative tothe eye.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion are configured to provide a tear fluid flowbetween the inner optic portion of the ophthalmic lens and the cornea.

In certain embodiments of an ophthalmic lens, the refractive error ofthe eye comprises astigmatism; and the anterior surface of the inneroptic portion and the posterior surface of the inner optic portion areradially symmetric.

In certain embodiments of an ophthalmic lens, the ophthalmic lensfurther comprises a plurality of fenestrations, wherein the plurality offenestrations is disposed within the inner optic portion, the peripheralportion, or both the inner optic portion and the peripheral portion.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are disposed proximate an interface betweenthe inner optic portion and the peripheral portion.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are configured to pump tear liquid betweenthe posterior surface of the lens and the epithelium when the eyeblinks.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are configured to maintain tear fluid withinone or more lenticular volumes between the posterior surface of theinner optic portion and the cornea.

In certain embodiments of an ophthalmic lens, the inner optic portion isprimarily configured to correct vision and the peripheral portion isprimarily configured to enhance comfort.

In certain embodiments of an ophthalmic lens, the posterior surface ofthe inner optic portion comprises a thickness of a low modulus material.

In certain embodiments of an ophthalmic lens, the ophthalmic lens ischaracterized by a sagittal height (SAG) from 3 to 5.

In certain embodiments of an ophthalmic lens, the anterior surface ischaracterized by a spherical profile without a cylindrical component.

In certain embodiments of an ophthalmic lens, the ophthalmic lenscomprises a reinforcement ring disposed proximate an interface betweenthe inner optic portion and the peripheral portion.

In certain embodiments of an ophthalmic lens, the reinforcement ring isembedded within the inner optic portion.

In certain embodiments of an ophthalmic lens, the reinforcement ring isdisposed within the inner optic portion and at a location that is notcoincident with the optical region of the cornea.

In certain embodiments of an ophthalmic lens, the reinforcement ring isformed from a material having a higher modulus than a modulus of amaterial forming the inner optic portion.

In certain embodiments of an ophthalmic lens, the ophthalmic lens isconfigured to center on the optical region of the cornea followingblinking of the eye.

In certain embodiments, methods for correcting a refractive error of aneye, the eye having a cornea with a refractive shape extending across anoptical region of the cornea, comprise: positioning an ophthalmic lenson the eye so that an inner optic portion of the ophthalmic lens isdisposed over the optical region of the cornea, wherein at least aportion of a posterior surface of the positioned ophthalmic lens extendsadjacent the eye and is deformed by the eye; and wherein a shape of theposterior surface diverges from the refractive shape of the cornea sothat the ophthalmic lens mitigates the refractive error.

In certain methods for correcting refractive error, an ophthalmic lenscomprises: a peripheral portion of the ophthalmic lens is disposedradially outward of the inner optic portion; and an anterior surface ofthe ophthalmic lens extends along the inner optic portion opposite theposterior surface, wherein, the inner optic portion is characterized byan inner rigidity and the peripheral portion is characterized by aperipheral rigidity; the inner rigidity is greater than the outerrigidity; and the inner rigidity is from about 1E6 MPa-μm³ to about 1E11MPa-μm³; and the posterior surface extends along the inner optic portionadjacent the eye when the inner optic portion is disposed over theoptical region, the posterior surface having a shape diverging from therefractive shape of the cornea.

In certain methods for correcting refractive error, following wearingthe lens for at least 30 minutes, an average comfort score in apopulation of patients is at least 6.5 out of 10 with a score of 10being most comfortable and corresponding to a comfort level withoutwearing the lens.

In certain methods for correcting refractive error, following thepositioning of the lens, an average corrected visual acuity in apopulation of patients having from 2.25DC to 3.00DC cylindrical error is0.1±0.15 Log MAR or better.

In certain methods for correcting refractive error, following thepositioning of the lens, an average corrected visual acuity in apopulation of patients having from 1.25DC to 2.00DC cylindrical error is0.0±0.15 Log MAR or better.

In certain methods for correcting refractive error, the refractive errorof the eye comprises astigmatism, spherical defocus, or a combinationthereof; the ophthalmic lens further comprises a plurality offenestrations, wherein the plurality of fenestrations is disposed withinthe inner optic portion, the peripheral portion, or both the inner opticportion and the peripheral portion; the inner portion of the ophthalmiclens is deformable and a peripheral portion of the ophthalmic lensdisposed outward of the inner optic portion is characterized by arigidity lower than a rigidity of the inner portion; and mitigation ofthe refractive error when viewing with the eye through the anteriorsurface is substantially independent of the shape of the peripheralportion throughout a range of astigmatic errors of at least about 1.5D,and is independent of a rotational orientation of the ophthalmic lensabout a viewing axis of the eye.

In certain embodiments, an ophthalmic lens for correcting a refractiveerror of an eye, the eye having a cornea with a refractive shapeextending across an optical region of the eye, comprises: an inner opticportion configured to be disposed over the optical region of the cornea;a posterior surface extending along the inner optic portion adjacent theeye when the inner optic portion is disposed over the optical region,the inner optic portion configured so that engagement of the posteriorsurface against the eye deforms the posterior surface and so that theposterior surface has a shape diverging from the refractive shape of thecornea; a peripheral portion of the ophthalmic lens disposed radiallyoutward of the inner optic portion; and a plurality of fenestrationsdisposed within the inner optic portion, the peripheral portion, or boththe inner optic portion and the peripheral portion; and at least some ofthe plurality of fenestrations are configured to maintain tear fluidwithin one or more lenticular volumes between the posterior surface ofthe inner optic portion and the cornea, and wherein: the anteriorsurface is characterized by a spherical profile without a cylindricalcomponent; the inner optic portion is characterized by an inner rigidityand the peripheral portion is characterized by a peripheral rigidity;the inner rigidity is greater than the outer rigidity; and the innerrigidity is from about 1E6 MPa-μm³ to about 1E11 MPa-μm³; and the inneroptic portion and the peripheral portion are characterized by a watercontent less than 5%.

In certain embodiments, the inner optic portion is characterized by amaximum thickness from about 50 μm to about 900 μm. The maximumthickness refers to the thickness at the center of the lens. In certainembodiments in which the lens has a spherical power, the thickness ofthe inner optic portion may decrease from the thickness at the centertoward the periphery of the inner optic portion. In certain embodiments,the maximum thickness of the inner optic portion may be from about 50 μmto 700 μm, from 100 μm to 600 μm, or from 100 μm to 400 μm.

In embodiments in which the inner optic portion is configured to providea spherical correction, the thickness of the inner portion will not beuniform, and will be shaped to provide, for example, a spherical powerfrom about −3.00 D to about +3.00 D. In such embodiments the thicknessof the inner optic portion can taper from the center toward theperipheral portion depending on the spherical power.

In embodiments, in which correction of spherical power is not required,the thickness of the inner portion may be substantially uniform.

In certain embodiments, ophthalmic lenses are radial symmetric.

Certain embodiments of ophthalmic lenses provided by the presentdisclosure can be configured to provide one or more lenticular volumesbetween at least a portion of the posterior surface of the inner opticportion and the surface of the cornea.

When placed on the cornea, the posterior surface of the inner opticportion of the ophthalmic lens comprises a shape diverging from therefractive shape of the cornea and define a lenticular volume. Incertain embodiments, at least a portion of the peripheral portion mayalso diverge from the refractive shape of the cornea and may define alenticular volume. The peripheral portion of the lens may diverge fromthe refractive shape of the cornea near the interface of the inner opticportion and the peripheral portion. Depending upon the shape of thecornea, one or more lenticular volumes may be formed

A lenticular volume defined by the peripheral portion of a lens may befluidly connected to a lenticular volume defined by the inner portionand may facilitate exchange of tear fluid within one or more lenticularvolumes. Tear exchange within a lenticular volume and to and from alenticular volume may be facilitated by fenestrations through theophthalmic lens. Such fenestrations may serve to pump tear fluid to andfrom a lenticular volume during blinking of the eye.

In certain embodiments, the inner optic portion comprises a shapeconfigured to provide a spherical power to correct refractive error, andin certain embodiments, comprises a shape configured to correctnon-spherical refractive error.

In certain embodiments, the anterior surface of the inner optic portionis characterized by a substantially spherical shape.

In certain embodiments, the posterior surface of the inner optic portionmay be characterized by a substantially spherical shape.

In other embodiments, the posterior surface of the inner optic portionmay be characterized by a non-spherical shape such as, for example, atoric shape. A lens in which the posterior surface is characterized by anon-spherical shape such as a toric shape is referred to as a bicurve orbitoric configuration. In embodiments in which the posterior surface ischaracterized by a toric shape, the shape can be configured such thatthe toric shape of inner optic portion aligns with an astigmatic axis ofthe cornea. The toric shape can reduce the lenticular volume compared toa spherical shape. The reduced lenticular volume results in less lensflexure of the contact lens during blinking.

A bitoric ophthalmic lens may have a bicurve surface on the posteriorsurface of the lens. A back surface bicurve design can improve thealignment of the lens with an astigmatic axis of the cornea. This hasthe advantage that there can be less space between the lens and thecornea, i.e., the lenticular volumes will be less, and may reduce theextent of flexure. In certain embodiments, a back surface bitoric designcan induce a small amount of astigmatism such as, for example, 20%.

In certain embodiments, an ophthalmic lens will have a spherical powereffect bitoric design that is independent of lens orientation. By addinga spherical power to the anterior surface of a back surface bicurvelens, the induced astigmatism can be corrected resulting in an opticallyspherical lens that is not sensitive to lens orientation.

In certain embodiments, the inner optic portion comprises a singlematerial throughout the thickness.

In certain embodiments, the inner optic portion comprises more than onematerial, with different materials disposed in different axial portionsof the inner optic portion. For example, the inner optic portion maycomprise a first portion disposed toward and/or forming the anteriorsurface of the inner optic portion, toward and/or forming the posteriorsurface of the inner optic portion, or toward the center of the inneroptic portion. In such embodiments, the first portion comprises amaterial characterized by a modulus higher than that of a materialforming the peripheral portion. The first portion comprises a materialand is characterized by a thickness sufficient to provide correction ofrefractive error.

In such embodiments, a first portion is configured to provide an opticalfunction by providing one or more lenticular volumes between theposterior surface and the cornea, by providing spherical power, and/orin bicurve designs providing a toric component. The first portioncomprises a material characterized by a modulus from about 100 MPa toabout 1500 MPa and can have a maximum thickness from about 50 μm toabout 900 μm. The thickness of the first portion may taper toward theinterface between the inner optic portion and the peripheral portion.The first portion can have a spherically shaped anterior surface and maybe shaped to provide a spherical power from about −3.00 D to about +3.00D.

One or more portions may be disposed anterior to the first portion,posterior to the first portion, or both anterior to and posterior to thefirst portion. In certain embodiments, an anterior and/or posteriorportion is formed from a material having a lower modulus than that ofthe first portion. In certain embodiments, an anterior and/or posteriorportion is characterized by a maximum thickness that is less than thatof the first portion. In certain embodiments, the anterior and/orposterior portions are configured to provide comfort, to modify thehydrophilicity/hydrophobicity of the inner optic portion, and/or toretain the first portion with the peripheral portion of the lens. Ingeneral, the anterior portion and/or posterior portion do not provide anoptical function. In certain embodiments, the anterior portion and/orthe posterior portion comprises a material having a modulus from about0.1 MPa to about 10 MPa and may have a maximum thickness from about 5 μmto about 100 μm. The thickness of the anterior portion and/or posteriorportion may be substantially the same across the radial profile or mayvary across the radial profile of the lens. The thickness of theanterior portions and the posterior portions may depend at least in parton the shape of the first portion. In certain embodiments, an anteriorportion and/or posterior portion comprises a hydrogel.

By virtue of being characterized by at least different moduli, thematerial forming the first portion is not structurally the same as theanterior material and/or the posterior material, although the materialsmay be based on similar chemistries and/or materials. In certainembodiments, the anterior material can be the same as the posteriormaterial and in certain embodiments the anterior material can bedifferent than the posterior material. In certain embodiments, theanterior material, the posterior material, and the peripheral materialare the same and the anterior material and the posterior material extendfrom the inner optic portion to the peripheral portion.

In certain embodiments, one or more surfaces of the first portion may betreated to enhance the mechanical integrity and/or adhesion of theinterface with the first portion and the anterior portion and/or theposterior portion.

FIG. 17A shows an ophthalmic lens having a first optic portion 1709having an anterior surface 1701 and a posterior surface 1710. Anteriorsurface 1701 is characterized by a spherical shape. First optic portion1709 is embedded or encapsulated within an anterior portion 1703 and aposterior portion 1704, which can be formed from a different materialthan that of the first optic portion. As shown in FIG. 17A, anteriorportion 1703 and posterior portion 1704 are contiguous with peripheralportion 1702 and can be formed from the same material.

FIG. 17B shows the ophthalmic lens of FIG. 17A positioned on a cornea1707. When positioned on a cornea having a non-spherical shape, theperipheral portion 1702 of the lens deforms to engage the anteriorsurface 1711 of the cornea 1707, and in certain regions, defineslenticular volumes 1706 between the posterior surface of the lens 1711and the anterior surface of the cornea. Rigidity provided by opticportion 1701 establishes a spherical profile of the posterior surface ofthe lens across the inner optic region such that the posterior surfaceof the lens spans non-spherical regions of the cornea to define one ormore lenticular volumes. FIG. 17B also shows fenestrations 1705extending through the ophthalmic lens, one of which is fluidly connectedto lenticular volume 1706. Fenestrations 1705 can facilitate tearexchange between the anterior surface of the lens and the lenticularvolume and between the anterior surface of the lens and the anteriorsurface of the cornea. Tear exchange can promote eye health and canmaintain fluid within lenticular volumes.

In certain embodiments, the inner optic portion, the peripheral portion,or both the inner optic portion and the peripheral portion may compriseone or more coatings on the anterior surface, the posterior surface, orboth the anterior surface and the posterior surface.

The one or more coatings may be selected, for example, to improvecomfort, to facilitate tear flow, and/or to modify thehydrophilicity/hydrophobicity of the lens or portion of the lens. Theone or more coatings may be the same in both the inner optic portion andin the peripheral portion or may be different in different portions ofthe lens.

In certain embodiments, the materials forming the inner optic portion,the peripheral portion, or both the inner optic portion and theperipheral portion are non-hydrous. A non-hydrous material refers to amaterial characterized by a water content less than about 10 wt %, lessthan about 5 wt %, and in certain embodiments, less than about 1 wt % inits fully hydrated state.

A material may be intrinsically non-hydrous or may be renderedfunctionally non-hydrous by situating or encapsulating a materialbetween non-hydrous materials and/or by a coating with a non-hydrousand/or hydrophobic material. For example, a hydrophobic coating such asan Oc Dy coating may be used to prevent hydration of a hydrous material.

The material forming the inner optic portion and the peripheral portionmay be characterized by the same or by a different water content.

In embodiments in which the inner optic portion comprises more than oneaxial portion, the first or optical portion may comprise a non-hydrousmaterial and the anterior portion and/or posterior portions may comprisea hydrous material, such as a hydrogel.

The inner optic portion comprises an inner material characterized by aninner modulus, and the peripheral portion comprises a peripheralmaterial characterized by a peripheral modulus, wherein the innermodulus is greater than the outer modulus.

In certain embodiments, the inner optic portion comprises a materialcharacterized by an inner modulus from about 100 MPa to about 3000 MPa.In certain embodiments, the inner modulus is from about 200 MPa to about3000 MPa, from about 200 MPa to about 2000 MPa, from about 200 MPa toabout 1500 MPa, from about 200 MPa to about 1000 MPa, and in certainembodiments, from about 200 MPa to about 700 MPa.

In certain embodiments, the peripheral portion comprises a materialcharacterized by a peripheral modulus from about 0.1 MPa to about 10MPa, from about 0.1 MPa to about 5 MPa, from about 0.5 MPa to about 5MPa, and in certain embodiments, from about 1 MPa to about 5 MPa.

The materials forming the inner optic portion and the peripheral portionmay be polymers, copolymers, homopolymers, graft polymers, or graftcopolymers. The materials may comprise a combination of more than onedifferent types of materials. In certain embodiments, the materials maybe hydrogels. A hydrogel refers to a cross-linked polymeric material,which is not water-soluble and contains at least 10 wt % water withinthe polymer matrix when fully hydrated. In certain embodiments, amaterial forming the inner optic portion and/or the peripheral portionis not a hydrogel and contains less than 10 wt % water.

Examples of suitable materials for forming the inner optic portioninclude, for example, silicones, fluorosilicones, polyurethanes,polyether block amides, polycarbonates, polymethyl methacrylates,polystyrenes, and acrylonitrile butadiene styrene, polymers ofmethacrylate and acrylate esters of various alcohols, includingaliphatic, aromatic, siloxane-containing, fluorocarbon-containingalcohols, and combinations of any of the foregoing. Such materials forthe inner optic portion are characterized by a modulus from about 100MPa to about 3000 MPa.

Examples of suitable materials for forming the peripheral portioninclude, for example, silicone, silicone hydrogels, and hydrogels ofoptically clear materials such as those listed for the inner portionmodified with a suitable hydrophilic material such aspolyhydroxyethylmethacrylate hydrogels, polyvinylpyrrolidone hydrogels,polyvinylalcohol hydrogels, silicone hydrogels.

Ophthalmic lenses provided by the present disclosure may be manufacturedusing any suitable contact lens manufacturing technology including, forexample, cast molding, injection molding, insert molding, transfermolding, thermoforming, vacuum forming, or a combination of any of theforegoing.

In certain embodiments, the inner optic portion comprising a highermodulus material may be thermoplastic and can be fabricated by injectionmolding. The inner optic portion may then be inserted into a mold cavityand the peripheral portion formed to retain the inner optic portion.This may be accomplished, for example, using insert molding or castmolding technologies. In certain embodiments, the material forming theperipheral portion also covers the anterior surface, the posteriorsurface, or both the anterior surface and the posterior surface of theinner portion. Cast molding resins may be, for example, heat cured orradiation cured such as UV cured.

EXAMPLES

Embodiments provided by the present disclosure are further illustratedby reference to the following examples, which describe the use ofcertain ophthalmic devices provided by the present disclosure. It willbe apparent to those skilled in the art that many modifications, both tomaterials, and methods, may be practiced without departing from thescope of the disclosure.

Example 1

A subject requiring an optical correction of −2.63 Diopters (OD) and−2.13 Diopters (OS) characteristic for a subject having myopia woreophthalmic lenses on both eyes for (very roughly) about 40 hours. Theinner and peripheral radii of curvature for the ophthalmic devices areprovided in Table 1. After about 40 hours, the ophthalmic lenses wereremoved and the amount of optical correction (Diopters) need to correctvision was determined at various times. The amount of optical correction(Diopters) needed after the ophthalmic lens was removed from thesubjects is presented in Table 2.

TABLE 2 Amount of optical correction (Diopters) needed after wearing anophthalmic lens. Radii of curvature for Amount of ophthalmic lenscorrection Inner Peripheral needed (prior Curve Curve Time followingophthalmic lens removal to shield wear) (degrees) (degrees) 5 min 2 hr 4hr 8 hr 24 hr 30 hr 48 hr Subject −2.63 39.5 43.0 −0.63 +0.13 +0.13 NM−0.50 −0.75 −1.25 #1 OD Subject −2.13 39.5 41.5 −0.63 −0.13 NM NM 0.000.00 −2.38 #1 OS *NM = No Measurement

Example 2

A subject requiring an optical correction of +0.13 Diopters (OD) and+0.25 Diopters (OS) characteristic for a subject having hyperopia woreophthalmic lenses on the right eye for (very roughly) about 35 hours,and on the left eye for (very roughly) about 17. The inner andperipheral radii of curvature for the ophthalmic devices are provided inTable 2. After about the specified number of hours, the ophthalmiclenses were removed and the amount of optical correction (Diopters) needto correct vision was determined at various times. The amount of opticalcorrection (Diopters) needed after the ophthalmic lens was removed fromthe subjects is presented in Table 3.

TABLE 3 Amount of optical correction (Diopters) needed after wearing anophthalmic lens. Radii of curvature for Amount of ophthalmic lenscorrection Inner Peripheral needed (prior Curve Curve Time followingophthalmic lens removal to shield wear) (degrees) (degrees) 5 min 2 hr 4hr 8 hr 24 hr 30 hr 48 hr Subject +0.13 39.5 43.0 −2.38 −3.13 −3.37−2.00 NM NM NM #2 OD Subject +0.25 39.5 41.5 −1.00 −1.25 NM NM 0.00 NMNM #2OS *NM = No Measurement

Example 3

A subject requiring an optical correction of −6.00DS-2.25DCX170 for theright eye (OD) and −6.50DS-2.50DCX005 for the left eye (OS). The K valuefor the right eye was 45.9/44.2 corresponding to a ΔK consistent with a1.70DC corneal cylinder, and the K value for the legt eye was 46.6/44.3orresponding to a ΔK consistent with a 2.30DC corneal cylinder. With anappropriately fitted conventional lens, the visual acuity in both eyeswas 20/20.

Following wearing an ophthalmic lens having an inner optic portion withspherical surfaces and characterized by a rigidity of about 1.1E10MPa-μm³ and a the peripheral portion comprises a material having amodulus from about 0.01 MPa to about 10 MPa, the visual acuity whenviewing with the right eye was 20/15-2 and with the left eye was 20/15.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, those of skill in theart will recognize that a variety of modifications, adaptations, andchanges may be employed. Hence, the scope of the present inventionshould be limited solely by the appended claims.

TABLE B1 R1 R1B1 R1B2 R1B3 R1 C2 14 mm center 5-7 7-9 9-11 13.5-14multicurve BC mm K mm K mm K mm K SAG designs (D) (D) (D) (D) (D) mm DIASteep K 36.5 43.50 42.25 39.50 <12 mm BC 3.1-3.4 13.8-14.1 mm (140micron thick) Medium 36.5 42.00 40.75 38.25 <12 mm BC 3.1-3.4 13.8-14.1mm (140 micron thick) Flat K 36.5 40.50 39.25 36.75 <12 mm BC 3.1-3.413.8-14.1 mm (140 micron thick) Steep K 38.5 44.25 43.00 40.25 <12 mm BC3.1-3.4 13.8-14.1 mm (140 micron thick) Medium 38.5 42.75 41.50 39.00<12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) Flat K 38.5 41.2540.00 37.50 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) Steep K40.5 45.00 43.75 41.00 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick)Medium 40.5 43.50 42.25 39.75 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micronthick) Flat K 40.5 42.00 40.75 38.25 <12 mm BC 3.1-3.4 13.8-14.1 mm (140micron thick)

TABLE B2 Flatter periphery design R1 R1B1 R1B2 R1B3 R1 C2 14 mm Center5-7 7-9 9-11 13.5-14 multicurve BC mm K mm K mm K mm K SAG designs (D)(D) (D) (D) (D) (mm) DIA Steep K 36.5 43.50 42.25 38.50 <12 mm BC3.1-3.4 13.8-14.1 mm (140 micron thick) Medium 36.5 42.00 40.75 37.25<12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) Flat K 36.5 40.5039.25 35.75 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) Steep K38.5 44.25 43.00 39.25 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick)Medium 38.5 42.75 41.50 38.00 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micronthick) Flat K 38.5 41.25 40.00 36.50 <12 mm BC 3.1-3.4 13.8-14.1 mm (140micron thick) Steep K 40.5 45.00 43.75 40.00 <12 mm BC 3.1-3.4 13.8-14.1mm (140 micron thick) Medium 40.5 43.50 42.25 38.75 <12 mm BC 3.1-3.413.8-14.1 mm (140 micron thick) Flat K 40.5 42.00 40.75 37.25 <12 mm BC3.1-3.4 13.8-14.1 mm (140 micron thick)

TABLE B3 Large shield R1B1 R1B2 R1B3 (16 mm) R1 5-7 7-9 9-10.5 10.5-13multicurve center mm K mm K mm K mm K 13-16 SAG designs BC (D) (D) (D)(D) mm* (mm) DIA Steep K 36.5 43.50 42.25 39.50 <10.0 mm/33.75 D <14.5mm/23 D ≦3.6 15.6-16.1 mm Medium 36.5 42.00 40.75 38.25 <10.0 mm/33.75 D<14.5 mm/23 D ≦3.6 15.6-16.1 mm Flat K 36.5 40.50 39.25 36.75 <10.0mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Steep K 38.5 44.25 43.0040.25 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Medium 38.5 42.7541.50 39.00 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Flat K 38.541.25 40.00 37.50 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm SteepK 40.5 45.00 43.75 41.00 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1mm Medium 40.5 43.50 42.25 39.75 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.615.6-16.1 mm Flat K 40.5 42.00 40.75 38.25 <10.0 mm/33.75 D <14.5 mm/23D ≦3.6 15.6-16.1 mm *may not tangent with previous curve (may insert anouter curve to help it flare)

TABLE B4 R1 R1B1 R1B2 R1B3 R1C center 5-7 7-9 9-11 13.5-14 Multicurve BCmm K mm K mm K mm K SAG CL designs (D) (D) (D) (D) (D) (mm) DIA CLcentral Steep K 40 41.75 39.00 39.00 <12 mm BC 3.1-3.4 13.8-14.1 mmcurve 1 (140 micron thick) Medium 40.00 39.75 37.25 37.25 <12 mm BC3.1-3.4 13.8-14.1 mm (140 micron thick) Flat K 40.00 37.75 35.25 35.25<12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) CL central Steep K42.00 43.75 41.00 41.00 <12 mm BC 3.1-3.4 13.8-14.1 mm curve 2 (140micron thick) Medium 42.00 41.75 39.25 39.25 <12 mm BC 3.1-3.4 13.8-14.1mm (140 micron thick) Flat K 42.00 39.75 37.25 37.25 <12 mm BC 3.1-3.413.8-14.1 mm (140 micron thick) CL central Steep K 44.000 44.75 42.0042.00 <12 mm BC 3.1-3.4 13.8-14.1 mm curve 3 (140 micron thick) Medium44.00 43.25 40.75 40.75 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micronthick) Flat K 44.00 41.75 39.25 39.25 <12 mm BC 3.1-3.4 13.8-14.1 mm(140 micron thick) CL central Steep K 46.00 46.75 44.00 44.00 <12 mm BC3.1-3.4 13.8-14.1 mm curve 4 (140 micron thick) Medium 46.00 45.25 42.7542.75 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick) Flat K 46.0043.75 41.25 41.25 <12 mm BC 3.1-3.4 13.8-14.1 mm (140 micron thick)

What is claimed is:
 1. An ophthalmic lens for correcting a refractiveerror of an eye, the eye comprising a cornea with a refractive shapeextending across an optical region of the cornea, the ophthalmic lenscomprising: an inner optic portion configured to be disposed over theoptical region of the cornea, wherein the inner optic portion comprisesan anterior surface, a first portion, and a posterior portion disposedposteriorly to the first portion; a posterior surface extending alongthe inner optic portion adjacent the eye and configured so thatengagement of the posterior surface against the cornea deforms theposterior surface and so that the posterior surface has a shapediverging from the refractive shape of the cornea and providing one ormore lenticular volumes between the posterior surface and the cornea; aperipheral portion of the ophthalmic lens disposed radially outward ofthe inner optic portion; and a plurality of fenestrations disposedwithin the inner optic portion, the peripheral portion, or both theinner optic portion and the peripheral portion; wherein at least some ofthe plurality of fenestrations are configured to maintain tear fluidwithin the one or more lenticular volumes between the posterior surfaceof the inner optic portion and the cornea; wherein the first portioncomprises a material characterized by a first modulus from about 20 MPato about 1500 MPa.
 2. The ophthalmic lens of claim 1, wherein theanterior surface is characterized by a spherical profile.
 3. Theophthalmic lens of claim 1, wherein the first portion is characterizedby a maximum thickness from about 50 μm to about 900 μm.
 4. Theophthalmic lens of claim 1, wherein, the posterior portion comprises aposterior material characterized by a posterior modulus; and theposterior modulus is less than the first modulus.
 5. The ophthalmic lensof claim 4, wherein the posterior modulus is from about 0.1 MPa to about10 MPa.
 6. The ophthalmic lens of claim 4, wherein the posterior portionis characterized by a thickness from about 5 μm to about 100 μm.
 7. Theophthalmic lens of claim 4, wherein the posterior material comprises ahydrogel.
 8. The ophthalmic lens of claim 1, wherein the first portioncomprises a hydrogel.
 9. The ophthalmic lens of claim 1, wherein thefirst portion and the posterior portion comprises silicon.
 10. Theophthalmic lens of claim 1, wherein the inner optic portion ischaracterized by a shape configured to provide spherical power from+10.00 D to −10.00D.
 11. The ophthalmic lens of claim 1, wherein theinner optic portion is characterized by a rigidity from 4E8 MPa-μm³ to1E10 MPa-μm³.
 12. The ophthalmic lens of claim 1, wherein the posteriorsurface is characterized by a bicurve profile.
 13. The ophthalmic lensof claim 10, wherein the bicurve profile comprises a toric component.14. The ophthalmic lens of claim 1, wherein, the cornea is characterizedby an optical axis; and the ophthalmic lens is configured to correctrefractive error independent of radial orientation with respect to theoptical axis.
 15. The ophthalmic lens of claim 1, wherein: therefractive error of the eye comprises a cylindrical error; and the inneroptic portion is characterized by a substantially spherical surface sothat correction of the cylindrical error by the lens is primarilyeffected by the divergence of the shape of the inner optic portion fromthe refractive shape of the cornea.
 16. The ophthalmic lens of claim 1,wherein at least some of the plurality of fenestrations are disposedproximate an interface between the inner optic portion and theperipheral portion.
 17. The ophthalmic lens of claim 1, wherein at leastsome of the plurality of fenestrations are configured to maintain tearfluid within the one or more lenticular volumes between the posteriorsurface of the inner optic portion and the cornea.
 18. The ophthalmiclens of claim 1, wherein at least some of the plurality of fenestrationsare configured to pump tear fluid between the posterior surface of thelens and the one or more lenticular volumes between the posteriorsurface and the cornea when the eye blinks.
 19. The ophthalmic lens ofclaim 1, wherein, the refractive error of the eye comprises astigmatism;and the anterior surface of the inner optic portion and the posteriorsurface of the inner optic portion are radially symmetric.
 20. A methodfor correcting a refractive error of an eye, the eye having a corneawith a refractive shape extending across an optical region of thecornea, the method comprising positioning the ophthalmic lens of claim 1on an eye comprising a refractive error, to correct the refractiveerror.
 21. The method of claim 20, wherein correction of the refractiveerror is substantially independent of the shape of the peripheralportion throughout a range of astigmatic errors of at least about 1.5D,and is independent of a rotational orientation of the ophthalmic lensabout a viewing axis of the eye.